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A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)

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ClinicalTrials.gov Identifier: NCT00945750
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : December 9, 2015
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heartburn
Interventions Drug: Famotidine FCT
Drug: Famotidine CT
Enrollment 30
Recruitment Details  
Pre-assignment Details Participants were randomized to 1 of 6 treatment sequences of 1 of 3 treatments: (1) famotidine as a film-coated tablet (FCT) taken with water, (2) famotidine as a chewable tablet (CTw) taken with water, and (3) famotidine as a chewable tablet taken without water, over 3 study periods in a crossover design.
Arm/Group Title FCT With Water / CT Without Water / CT With Water CT Without Water / CT With Water / FCT With Water CT With Water / FCT With Water / CT Without Water FCT With Water / CT With Water / CT Without Water CT Without Water / FCT With Water / CT With Water CT With Water / CT Without Water / FCT With Water
Hide Arm/Group Description Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water. Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water. Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water. Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water. Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water. Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
Period Title: Period I
Started 5 5 5 5 5 5
Completed 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0
Period Title: Period II
Started 5 5 5 5 5 5
Completed 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0
Period Title: Period III
Started 5 5 5 5 5 5
Completed 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0
Arm/Group Title FCT With Water / CT Without Water / CT With Water CT Without Water / CT With Water / FCT With Water CT With Water / FCT With Water / CT Without Water FCT With Water / CT With Water / CT Without Water CT Without Water / FCT With Water / CT With Water CT With Water / CT Without Water / FCT With Water Total
Hide Arm/Group Description Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water. Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water. Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water. Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water. Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water. Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water. Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 5 5 5 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants 30 participants
32.4  (5.32) 24.0  (7.38) 24.2  (4.38) 22.6  (3.51) 26.4  (6.11) 25.6  (6.50) 25.9  (6.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants 30 participants
Female
4
  80.0%
2
  40.0%
0
   0.0%
2
  40.0%
4
  80.0%
2
  40.0%
14
  46.7%
Male
1
  20.0%
3
  60.0%
5
 100.0%
3
  60.0%
1
  20.0%
3
  60.0%
16
  53.3%
Weight  
Mean (Full Range)
Unit of measure:  Pounds
Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants 30 participants
137.6
(106.9 to 158.4)
163.0
(140.6 to 187.1)
175.4
(139.6 to 195.0)
147.9
(110.9 to 182.2)
142.6
(113.9 to 185.1)
180.4
(140.6 to 205.9)
157.4
(106.9 to 205.9)
1.Primary Outcome
Title Area Under the Concentration-time Curve From 0 to Infinity (AUC 0-∞) Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
Hide Description AUC values were natural log-transformed and analyzed using an analysis of variance (ANOVA) model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Time Frame 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study
Arm/Group Title Famotidine 20 mg CT Without Water Famotidine 20 mg FCT With Water
Hide Arm/Group Description:
Famotidine 20 mg CT without water
Famotidine 20 mg FCT with 120 mL of water
Overall Number of Participants Analyzed 30 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL hr
398.5
(350.9 to 452.6)
394.8
(347.6 to 448.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine 20 mg CT Without Water, Famotidine 20 mg FCT With Water
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.01
Confidence Interval 90%
0.94 to 1.09
Estimation Comments [Not Specified]
2.Primary Outcome
Title Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine CT Without Water and Famotidine FCT With Water
Hide Description Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Time Frame 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study
Arm/Group Title Famotidine 20 mg CT Without Water Famotidine 20 mg FCT With Water
Hide Arm/Group Description:
Famotidine 20 mg CT without water
Famotidine 20 mg FCT with 120 mL of water
Overall Number of Participants Analyzed 30 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
67.2
(58.7 to 76.9)
65.1
(56.9 to 74.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine 20 mg CT Without Water, Famotidine 20 mg FCT With Water
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.03
Confidence Interval 90%
0.93 to 1.14
Estimation Comments [Not Specified]
3.Secondary Outcome
Title AUC 0-∞ Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
Hide Description AUC values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Time Frame 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study
Arm/Group Title Famotidine 20 mg CT With Water Famotidine 20 mg FCT With Water
Hide Arm/Group Description:
Famotidine 20 mg CT with 120 mL of water
Famotidine 20 mg FCT with 120 mL of water
Overall Number of Participants Analyzed 30 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL hr
440.1
(387.5 to 499.8)
394.8
(347.6 to 448.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine 20 mg CT With Water, Famotidine 20 mg FCT With Water
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.11
Confidence Interval 90%
1.04 to 1.20
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Cmax of Famotidine Following Single Dose Administration of Famotidine CT With Water and Famotidine FCT With Water
Hide Description Cmax values were natural log-transformed and analyzed using an ANOVA model. The ANOVA model contained factors for participant (random effect), period, treatment, and within-participant error.
Time Frame 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study
Arm/Group Title Famotidine 20 mg CT With Water Famotidine 20 mg FCT With Water
Hide Arm/Group Description:
Famotidine 20 mg CT with 120 mL of water
Famotidine 20 mg FCT with 120 mL of water
Overall Number of Participants Analyzed 30 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: ng/mL
73.0
(63.8 to 83.6)
65.1
(56.9 to 74.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Famotidine 20 mg CT With Water, Famotidine 20 mg FCT With Water
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.12
Confidence Interval 90%
1.02 to 1.24
Estimation Comments [Not Specified]
Time Frame Up to 31 days (including 14 day follow-up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Famotidine 20 mg FCT With Water Famotidine 20 mg CT Without Water Famotidine 20 mg CT With Water
Hide Arm/Group Description Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water Famotidine 20 mg Chewable Tablet without water Famotidine 20 mg chewable tablet with 120 mL of water
All-Cause Mortality
Famotidine 20 mg FCT With Water Famotidine 20 mg CT Without Water Famotidine 20 mg CT With Water
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Famotidine 20 mg FCT With Water Famotidine 20 mg CT Without Water Famotidine 20 mg CT With Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Famotidine 20 mg FCT With Water Famotidine 20 mg CT Without Water Famotidine 20 mg CT With Water
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/30 (13.33%)      3/30 (10.00%)      4/30 (13.33%)    
Nervous system disorders       
Dizziness  1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0
Headache  1  3/30 (10.00%)  4 3/30 (10.00%)  3 3/30 (10.00%)  4
Respiratory, thoracic and mediastinal disorders       
Rhinitis  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1
Vascular disorders       
Syncope vasovagal  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
Merck must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by Merck as confidential must be deleted prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00945750     History of Changes
Other Study ID Numbers: 0208-144
2009_621 ( Other Identifier: Merck Registration Number )
First Submitted: July 22, 2009
First Posted: July 24, 2009
Results First Submitted: August 17, 2015
Results First Posted: December 9, 2015
Last Update Posted: March 10, 2017