Pharmacokinetics of Faldaprevir of Soft Capsule

Study Overview
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Brief Summary
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The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single oral dose and multiple oral doses in Chinese subjects

Official Title
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Pharmacokinetics of Single and Multiple Oral Doses of 120 mg and 240 mg BI 201335 in Healthy Chinese Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: faldaprevir(high dose)
* Drug: Faldaprevir(low dose)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Healthy male and female subjects Exclusion criteria: Any relevant deviation from healthy conditionsAny relevant deviation from healthy conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: faldaprevir(high dose)<br>10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose. | Drug: faldaprevir(high dose)<br>* faldaprevir(high dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to high dose treatment in random order<br>|
| Experimental: Faldaprevir(low dose)<br>10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose. | Drug: Faldaprevir(low dose)<br>* faldaprevir(low dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to low dose treatment in random order<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss (After Multiple Dosing) | C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau. | Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir | 
| AUC(Tau,ss) (After Multiple Dosing) | AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau. | Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (After Single Dosing) | Cmax is defined as maximum measured concentration of Faldaprevir in plasma. | Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir | 
| AUC(0-tz) (After Single Dosing) | AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval. | Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir | 
| t(1/2,ss) (After Multiple Dosing) | t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state. | Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir | 
| Tmax,ss (After Multiple Dosing) | tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state | Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir |