Pharmacokinetics of Faldaprevir of Soft Capsule

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: faldaprevir(high dose); Drug: Faldaprevir(low dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01821937

1220.52

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditionsAny relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

faldaprevir(high dose)

Experimental group

Description:

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

Treatment:

Drug: faldaprevir(high dose)

Faldaprevir(low dose)

Experimental group

Description:

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

Treatment:

Drug: Faldaprevir(low dose)