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Pharmacokinetics of Faldaprevir of Soft Capsule

NCT ID: NCT01821937

Last Updated: 2015-08-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-05-31

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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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faldaprevir(high dose)

10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.

Group Type EXPERIMENTAL

faldaprevir(high dose)

Intervention Type DRUG

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

Faldaprevir(low dose)

10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.

Group Type EXPERIMENTAL

Faldaprevir(low dose)

Intervention Type DRUG

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

Interventions

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faldaprevir(high dose)

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

Intervention Type DRUG

Faldaprevir(low dose)

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1220.52.86001 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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1220.52

Identifier Type: -

Identifier Source: org_study_id

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