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TMC278-TiDP6-C136: Effect of TMC278 on Ethinylestradiol and Norethindrone in Healthy Women.

NCT00739622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2010-04-28

No results posted yet for this study

Summary

The purpose of this study is to investigate the pharmacokinetic interaction between the combination of ethinylestradiol and norethindrone and TMC278 25 mg once daily. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. Furthermore the short-term safety and tolerability (how well the body tolerates the drug) of co-administration of TMC278 and ethinylestradiol and norethindrone, in healthy women, will be assessed.

Conditions

  • HIV
  • AIDS
  • Oral Contraceptive

Interventions

DRUG

TMC278

Sponsors & Collaborators

  • Tibotec Pharmaceuticals, Ireland

    lead INDUSTRY

Principal Investigators

  • Tibotec Pharmaceuticals Limited Clinical Trial · Tibotec Pharmaceutical Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

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Entities

Diseases

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 NCT00739622 on ClinicalTrials.gov