MedTrace Logo

Bioequivalence Trial of 2 Dose Strengths of BI 201335 NA Soft Gelatine Capsules

NCT01704846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-31

Study results available
· View outcomes & findings →

Summary

The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.

Conditions

  • Hepatitis C

Interventions

DRUG

BI 201335 NA 120 mg capsule

1capsule of BI 201335 NA 120 mg capsule

DRUG

BI 201335 NA 120 mg capsule

1 capsule of BI 201335 NA 120 mg capsule

DRUG

BI 201335 NA 40 mg capsule

3 capsules of BI 201335 NA 40 mg capsule

DRUG

BI 201335 NA 40 mg capsule

3 capsules of BI 201335 NA 40 mg capsule

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01704846 on ClinicalTrials.gov