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Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule

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ClinicalTrials.gov Identifier: NCT02382640
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : April 29, 2016
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteers
Interventions Drug: Febuxostat XR
Drug: Maalox Advance Regular Strength liquid
Enrollment 36
Recruitment Details Participants took part in the study at 1 investigative site in United States from 23-Feb-15 to 04-May-15.
Pre-assignment Details Healthy participants were enrolled in this 4 period cross over study to receive 4 regimens which included febuxostat extended release (XR) 80 milligram (mg) and Maalox suspension 20 milliliter (mL) based on different fasting conditions.
Arm/Group Title Regimen A, Then B, Then D, Then C Regimen D, Then A, Then C, Then B Regimen C, Then D, Then B, Then A Regimen B, Then C, Then A, Then D
Hide Arm/Group Description Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days). Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]). Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days). Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
Period Title: Intervention Period 1 (3 Days)
Started 9 9 9 9
Completed 9 9 9 9
Not Completed 0 0 0 0
Period Title: Washout Period 1 (7 Days)
Started 9 9 9 9
Completed 9 9 9 9
Not Completed 0 0 0 0
Period Title: Intervention Period 2 (3 Days)
Started 9 9 9 9
Completed 9 9 9 9
Not Completed 0 0 0 0
Period Title: Washout Period 2 (7 Days)
Started 9 9 9 9
Completed 9 9 9 9
Not Completed 0 0 0 0
Period Title: Intervention Period 3 (3 Days)
Started 9 9 9 9
Completed 9 9 9 9
Not Completed 0 0 0 0
Period Title: Washout Period 3 (7 Days)
Started 9 9 9 9
Completed 9 9 9 9
Not Completed 0 0 0 0
Period Title: Intervention Period 4 (3 Days)
Started 9 9 9 9
Completed 8 9 9 9
Not Completed 1 0 0 0
Reason Not Completed
Laboratory Abnormality             1             0             0             0
Arm/Group Title Regimen A, Then B, Then D, Then C Regimen D, Then A, Then C, Then B Regimen C, Then D, Then B, Then A Regimen B, Then C, Then A, Then D Total
Hide Arm/Group Description Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days). Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]). Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days). Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days). Total of all reporting groups
Overall Number of Baseline Participants 9 9 9 9 36
Hide Baseline Analysis Population Description
The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
37.8  (7.36) 34.7  (13.42) 31.7  (9.18) 35.8  (11.38) 35.0  (10.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Female
5
  55.6%
5
  55.6%
5
  55.6%
6
  66.7%
21
  58.3%
Male
4
  44.4%
4
  44.4%
4
  44.4%
3
  33.3%
15
  41.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Hispanic or Latino 5 3 4 5 17
Not Hispanic or Latino 4 6 5 4 19
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Black or African American 1 2 4 3 10
White 8 6 5 5 24
Multiracial 0 1 0 1 2
Smoking classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Has never smoked 8 9 8 8 33
Is an ex-smoker 1 0 1 1 3
Alcohol classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Has never drunk 2 4 5 4 15
Is a current drinker 4 1 1 2 8
Is an ex-drinker 3 4 3 3 13
Xanthine/caffeine consumption  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Had xanthine/caffeine consumption 5 5 3 5 18
Had no xanthine/caffeine consumption 4 4 6 4 18
Female reproductive status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 9 participants 9 participants 36 participants
Female of childbearing potential 4 5 4 4 17
Surgically sterile 1 0 1 2 4
N/A (participant is male) 4 4 4 3 15
1.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for Febuxostat
Hide Description [Not Specified]
Time Frame Days 1 at multiple timepoints (up to 48 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
883.58  (898.49) 1075.08  (941.46) 765.89  (480.2) 1456.42  (875.39)
2.Primary Outcome
Title AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat
Hide Description [Not Specified]
Time Frame Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
4680.69  (2427.11) 5877.99  (2888.9) 4412.22  (1718.42) 7316.21  (2811.1)
3.Primary Outcome
Title AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat
Hide Description [Not Specified]
Time Frame Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
5901  (2739.92) 6999.9  (2912.71) 4844.33  (1918.73) 7697.85  (2732.63)
4.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Measure Type: Number
Unit of Measure: participants
TEAE 2 1 3 2
SAE 0 0 0 0
5.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description [Not Specified]
Time Frame Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Measure Type: Number
Unit of Measure: participants
0 0 0 0
6.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings
Hide Description [Not Specified]
Time Frame Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Measure Type: Number
Unit of Measure: participants
0 0 0 0
7.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation
Hide Description [Not Specified]
Time Frame Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Measure Type: Number
Unit of Measure: participants
0 0 0 0
8.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)
Hide Description [Not Specified]
Time Frame Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description:
Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
Overall Number of Participants Analyzed 36 36 35 36
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Regimen A Regimen B Regimen C Regimen D
Hide Arm/Group Description Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods. Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods. Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
All-Cause Mortality
Regimen A Regimen B Regimen C Regimen D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Regimen A Regimen B Regimen C Regimen D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/35 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regimen A Regimen B Regimen C Regimen D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/36 (5.56%)   1/36 (2.78%)   3/35 (8.57%)   2/36 (5.56%) 
Gastrointestinal disorders         
Diarrhoea  1  1/36 (2.78%)  0/36 (0.00%)  1/35 (2.86%)  0/36 (0.00%) 
Nausea  1  0/36 (0.00%)  0/36 (0.00%)  1/35 (2.86%)  0/36 (0.00%) 
Injury, poisoning and procedural complications         
Oral herpes  1  1/36 (2.78%)  0/36 (0.00%)  0/35 (0.00%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  0/36 (0.00%)  0/36 (0.00%)  0/35 (0.00%)  1/36 (2.78%) 
Nervous system disorders         
Dizziness  1  0/36 (0.00%)  0/36 (0.00%)  0/35 (0.00%)  1/36 (2.78%) 
Headache  1  0/36 (0.00%)  0/36 (0.00%)  1/35 (2.86%)  0/36 (0.00%) 
Skin and subcutaneous tissue disorders         
Ecchymosis  1  0/36 (0.00%)  1/36 (2.78%)  0/35 (0.00%)  0/36 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02382640     History of Changes
Other Study ID Numbers: Febuxostat XR-1010
U1111-1163-1813 ( Registry Identifier: WHO )
First Submitted: March 3, 2015
First Posted: March 9, 2015
Results First Submitted: March 28, 2016
Results First Posted: April 29, 2016
Last Update Posted: April 29, 2016