Pharmacokinetics of Faldaprevir of Soft Capsule

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: faldaprevir(high dose); Drug: Faldaprevir(low dose)

• Registration Number: NCT01821937
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-04-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-07
• Results First Submitted: 2015-07-03
• Results First Submitted QC: 2015-07-03
• Last Update Submitted: 2015-07-03
• Results First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
faldaprevir(high dose)	faldaprevir(high dose)	10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.
Faldaprevir(low dose)	Faldaprevir(low dose)	10 subjects (approximate sex ration: 1:1) will be assigned to trial by single and multiple dose.

Primary Outcome Measures

Name	Time	Method
Cmax,ss (After Multiple Dosing)	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.
AUC(Tau,ss) (After Multiple Dosing)	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

Name	Time	Method
Cmax (After Single Dosing)	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.
AUC(0-tz) (After Single Dosing)	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.
t(1/2,ss) (After Multiple Dosing)	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.
Tmax,ss (After Multiple Dosing)	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

Trial Locations

Locations (1)

1220.52.86001 Boehringer Ingelheim Investigational Site; 🇨🇳 Beijing, China