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drugset / Trial / NCT03127189

A Study to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension in Healthy Participants

NCT03127189 ↗

Phase 1 Completed 110 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelOther

Summary

The main purpose of this study is to characterize the single-dose pharmacokinetics (PK) of rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV LA) nanosuspensions with different particle size distribution (PSD), in healthy adult participants.

Timeline

Start
2017-04-20
Primary completion
2018-04-10
Completion
2018-04-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilpivirine Small molecule 25 mg Oral
Subject Rilpivirine Small molecule 600 mg Oral

Indications

No indication recorded.