A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
NCT01719614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2014-03-06
Summary
The purpose of the study is to evaluate the effect of steady-state (constant concentration of medication in the blood) rilpivirine on pharmacokinetics (how a single dose of metformin is absorbed in the body, distributed within the body, and removed from the body) of a single dose of metformin, over time, in healthy adult participants.
Conditions
- Healthy Participants
Interventions
- DRUG
-
Type=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15.
- DRUG
-
Rilpivirine
Type=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17.
Sponsors & Collaborators
-
Janssen R&D Ireland
lead INDUSTRY
Principal Investigators
-
Janssen R&D Ireland Clinical Trial · Janssen R&D Ireland
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-10-31
- Primary Completion
- 2013-01-31
- Completion
- 2013-01-31
Countries
- United States
Study Locations
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