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Completed

NCT Number: NCT01821937

Pharmacokinetics of Faldaprevir of Soft Capsule

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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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1220.52.86001 Boehringer Ingelheim Investigational Site

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male and female subjects

Exclusion criteria

Any relevant deviation from healthy conditionsAny relevant deviation from healthy conditions

Treatment and study plan

faldaprevir(high dose)

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)

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

Primary outcomes

  1. Cmax,ss (After Multiple Dosing)

    Time frame: 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

    C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.

  2. AUC(Tau,ss) (After Multiple Dosing)

    Time frame: 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) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.

Secondary outcomes

  1. Cmax (After Single Dosing)

    Time frame: 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

    Cmax is defined as maximum measured concentration of Faldaprevir in plasma.

  2. AUC(0-tz) (After Single Dosing)

    Time frame: 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) 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.

  3. t(1/2,ss) (After Multiple Dosing)

    Time frame: 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

    t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.

  4. Tmax,ss (After Multiple Dosing)

    Time frame: 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 is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 1, 2013
Registry last updated
Aug 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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