At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 8 enrolled
Drug / intervention
Darunavir/Cobicistatdrug
Likely dose
Darunavir/Cobicistat 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single-oral Administration of Darunavir/Cobicistat Fixed-Dose Combination Tablet in Healthy Japanese Adult Subjects
In Brief
A Phase 4 clinical trial evaluating Darunavir/Cobicistat for Healthy. Completed, enrolled 8 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI fixed-dose combination tablet) in healthy Japanese adult participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
Enrollment StartApr 2017
First PostedApr 2017
Primary CompletionMay 2017
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartApr 14, 2017
Primary CompletionMay 19, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.2 years ago
Interventions
Darunavir/Cobicistatdrug
Participants will receive a FDC tablet of darunavir 800 mg and cobicistat 150 mg orally in the morning of Day 1.