Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 28 for:    RNA | BI 201335 OR faldaprevir

Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704846
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: BI 201335 NA 120 mg capsule
Drug: BI 201335 NA 40 mg capsule
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2
Hide Arm/Group Description

Treatment sequence: Test - Reference - Reference - Test

Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.

Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.

Treatments were separated by a washout period of at least 14 days.

Treatment sequence: Reference - Test - Test - Reference

Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.

Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.

Treatments were separated by a washout period of at least 14 days.

Period Title: Treatment Period 1
Started 30 30
Completed 30 30
Not Completed 0 0
Period Title: Treatment Period 2
Started 30 30
Completed 30 29
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Treatment Period 3
Started 30 29
Completed 30 29
Not Completed 0 0
Period Title: Treatment Period 4
Started 30 29
Completed 30 29
Not Completed 0 0
Arm/Group Title Treatment Sequence 1 Treatment Sequence 2 Total
Hide Arm/Group Description

Treatment sequence: Test - Reference - Reference - Test

Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.

Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.

Treatments were separated by a washout period of at least 14 days.

Treatment sequence: Reference - Test - Test - Reference

Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.

Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.

Treatments were separated by a washout period of at least 14 days.

Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
Treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
28.1  (5.7) 30.1  (5.8) 29.1  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
30
 100.0%
30
 100.0%
60
 100.0%
1.Primary Outcome
Title Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)
Hide Description

Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.

Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.

Time Frame 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description:
Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Overall Number of Participants Analyzed 59 60
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
118 119
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng·h/mL
17297.157
(19.71%)
17216.514
(23.89%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product: Faldaprevir 40 mg x 3 Capsules, Reference Product: Faldaprevir 120 mg x 1 Capsule
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.
Method of Estimation Estimation Parameter Adjusted Geometric Mean Ratio (%)
Estimated Value 100.47
Confidence Interval (2-Sided) 90%
95.90 to 105.25
Estimation Comments Ratio calculated as Test product divided by reference product
2.Primary Outcome
Title Maximum Measured Concentration (Cmax)
Hide Description Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description:
Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Overall Number of Participants Analyzed 59 60
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
118 119
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
943.868
(32.16%)
916.480
(39.22%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product: Faldaprevir 40 mg x 3 Capsules, Reference Product: Faldaprevir 120 mg x 1 Capsule
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.
Method of Estimation Estimation Parameter Adjusted Geometric Mean Ratio (%)
Estimated Value 102.99
Confidence Interval (2-Sided) 90%
95.57 to 110.98
Estimation Comments Ratio calculated as Test product divided by reference product
3.Secondary Outcome
Title Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Hide Description

Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.

Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.

Time Frame 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description:
Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Overall Number of Participants Analyzed 59 60
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
118 119
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
18422.006
(19.07%)
18323.189
(23.18%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product: Faldaprevir 40 mg x 3 Capsules, Reference Product: Faldaprevir 120 mg x 1 Capsule
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.
Method of Estimation Estimation Parameter Adjusted Geometric Mean Ratio (%)
Estimated Value 100.54
Confidence Interval (2-Sided) 90%
96.10 to 105.18
Estimation Comments Ratio calculated as Test product divided by reference product
4.Secondary Outcome
Title Time From Dosing to the Maximum Measured Concentration (Tmax)
Hide Description

Time from dosing to the maximum measured concentration of the analyte in plasma.

Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation.

Time Frame 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description:
Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Overall Number of Participants Analyzed 59 60
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
118 119
Mean (Standard Deviation)
Unit of Measure: hours
4.478  (25.60) 4.585  (31.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product: Faldaprevir 40 mg x 3 Capsules, Reference Product: Faldaprevir 120 mg x 1 Capsule
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.
Method of Estimation Estimation Parameter Adjusted Mean Ratio (%)
Estimated Value 97.66
Confidence Interval (2-Sided) 90%
91.54 to 103.78
Estimation Comments Ratio calculated as Test product divided by reference product
5.Secondary Outcome
Title Terminal Rate Constant (λz)
Hide Description Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description:
Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Overall Number of Participants Analyzed 59 60
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
118 119
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.0265
(9.91%)
0.0264
(6.91%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product: Faldaprevir 40 mg x 3 Capsules, Reference Product: Faldaprevir 120 mg x 1 Capsule
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.
Method of Estimation Estimation Parameter Adjusted Geometric Mean Ratio (%)
Estimated Value 100.34
Confidence Interval (2-Sided) 90%
98.51 to 102.20
Estimation Comments Ratio calculated as Test product divided by reference product
6.Secondary Outcome
Title Terminal Half-life (t1/2)
Hide Description Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description:
Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Overall Number of Participants Analyzed 59 60
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
118 119
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
26.204
(9.91%)
26.293
(6.91%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product: Faldaprevir 40 mg x 3 Capsules, Reference Product: Faldaprevir 120 mg x 1 Capsule
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.
Method of Estimation Estimation Parameter Adjusted Geometric Mean Ratio (%)
Estimated Value 99.66
Confidence Interval (2-Sided) 90%
97.85 to 101.51
Estimation Comments Ratio calculated as Test product divided by reference product
7.Secondary Outcome
Title Mean Residence Time (MRTpo)
Hide Description Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.
Time Frame 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description:
Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
Overall Number of Participants Analyzed 59 60
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
118 119
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
29.948
(9.93%)
29.888
(9.79%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Product: Faldaprevir 40 mg x 3 Capsules, Reference Product: Faldaprevir 120 mg x 1 Capsule
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.
Method of Estimation Estimation Parameter Adjusted Geometric Mean Ratio (%)
Estimated Value 100.20
Confidence Interval (2-Sided) 90%
98.10 to 102.34
Estimation Comments Ratio calculated as Test product divided by reference product
Time Frame Four treatment periods (Period 1 to 4) of 6 days for each (Days -1 to 5) + Washout period of at least 14 days between treatments
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Hide Arm/Group Description Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
All-Cause Mortality
Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test Product: Faldaprevir 40 mg x 3 Capsules Reference Product: Faldaprevir 120 mg x 1 Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   7/59 (11.86%)   8/60 (13.33%) 
Gastrointestinal disorders     
Diarrhoea  1  3/59 (5.08%)  3/60 (5.00%) 
Gastroenteritis  1  4/59 (6.78%)  5/60 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 15.1
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01704846     History of Changes
Other Study ID Numbers: 1220.53
First Submitted: October 9, 2012
First Posted: October 12, 2012
Results First Submitted: July 3, 2015
Results First Posted: July 31, 2015
Last Update Posted: July 31, 2015