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Trial record 11 of 50 for:    BI 201335 OR faldaprevir

Pharmacokinetics of Faldaprevir of Soft Capsule

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ClinicalTrials.gov Identifier: NCT01821937
Recruitment Status : Completed
First Posted : April 1, 2013
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: faldaprevir(high dose) Drug: Faldaprevir(low dose) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Single and Multiple Oral Doses of 120 mg and 240 mg BI 201335 in Healthy Chinese Volunteers
Study Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: faldaprevir(high dose)
10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.
Drug: 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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditionsAny relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821937


Locations
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China
1220.52.86001 Boehringer Ingelheim Investigational Site
Beijing, China
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01821937     History of Changes
Other Study ID Numbers: 1220.52
First Posted: April 1, 2013    Key Record Dates
Results First Posted: August 3, 2015
Last Update Posted: August 3, 2015
Last Verified: July 2015