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TMC435-TiDP16-C116 - Relative Bioavailability and Food Effect Study

NCT01308606 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-10-11

No results posted yet for this study

Summary

The purpose of this study is to compare absorption of TMC435 formulated as 2 different types of capsules. After that, the absorption of one chosen TMC435 capsule will be compared when taken under fasting conditions or together with a standard or a high-fat meal. This will be done in healthy volunteers.

Conditions

  • Hepatitis C

Interventions

DRUG

TMC435 HPMC capsule

Single intake of one 150-mg capsule without food

DRUG

TMC435 HPMC or gelatin capsule

Single intake of one 150-mg capsule after high-fat breakfast

DRUG

TMC435 HPMC or gelatin capsule

Single intake of one 150-mg capsule without food

DRUG

TMC435 HPMC or gelatin capsule

Single intake of one 150-mg capsule after standardized breakfast

DRUG

TMC435 gelatin capsule

Single intake of one 150-mg capsule without food

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Completion
2011-06-30

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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 NCT01308606 on ClinicalTrials.gov