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

Study Overview
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Brief Summary
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The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Official Title
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Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: BI 201335 NA 120 mg capsule
* Drug: BI 201335 NA 120 mg capsule
* Drug: BI 201335 NA 40 mg capsule
* Drug: BI 201335 NA 40 mg capsule


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male volunteers without any clinical significant findings and complications Age: 20 - 45 years BMI: 18.5 - 25.0 kg/m2 Signed informed consent Exclusion criteria: Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance. Any evidence of a clinically relevant concomitant disease according to investigator's clinical judgement. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. History of jaundice Surgery of the gastrointestinal tract (except appendectomy). Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders. History of relevant orthostatic hypotension, fainting spells or blackouts. Chronic or relevant acute infections. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) according to investigator's clinical judgement. Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial Use of drugs which might reasonably influence the results (pharmacokinetic) of the trial within at least 10 days prior to administration or during the trial. Participation in another trial with an investigational drug within two months prior to administration or during the trial. Smoking (>10 cigarettes or >3 cigars or >3 pipes/day). Inability to refrain from smoking during the trial. Alcohol abuse (more than 60 g/day: e.g., 3 middle-sized bottles of beer, 3 gous [equivalent to 540 mL] of sake). Drug abuse. Blood donation (more than 100 mL within four weeks prior to administration). Excessive physical activities (within one week prior to administration). Any laboratory value outside the reference range that is of clinical relevance according to investigator's clinical judgement. Any history of relevant liver diseases (for instance, disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, or previous liver tumours).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment sequence 1<br>Test - Reference - Reference - Test | Drug: BI 201335 NA 120 mg capsule<br>* 1 capsule of BI 201335 NA 120 mg capsule<br>Drug: BI 201335 NA 40 mg capsule<br>* 3 capsules of BI 201335 NA 40 mg capsule<br>|
| Experimental: Treatment sequence 2<br>Reference - Test - Test - Reference | Drug: BI 201335 NA 120 mg capsule<br>* 1capsule of BI 201335 NA 120 mg capsule<br>Drug: BI 201335 NA 40 mg capsule<br>* 3 capsules of BI 201335 NA 40 mg capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz) | 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. | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | 
| Maximum Measured Concentration (Cmax) | 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. | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) | 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. | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | 
| Time From Dosing to the Maximum Measured Concentration (Tmax) | 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. | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | 
| Terminal Rate Constant (λz) | 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. | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | 
| Terminal Half-life (t1/2) | 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. | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration | 
| Mean Residence Time (MRTpo) | 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. | 3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration |