Healthy Participants Clinical Trial
Official title:
A Single-Dose, Open-Label, 3-Panel, Randomized, Pivotal Crossover Study to Assess the Bioequivalence of Darunavir When Co-Administrated With Cobicistat as Either a Fixed Dose Combination Tablet (G006) or as Single Agents Under Fed and Fasted Conditions in Healthy Subjects
The purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.
This is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to switch patients from one treatment arm to another in a clinical trial) study in 134 healthy adult participants. The study consists of 3 phases including a screening phase of approximately 3 weeks (Days -21 to -1) followed by an open-label treatment phase consisting of 3 panels with 2 single-dose treatment sessions of 5 days each (Days -1 to 4) separated by a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last intake of study drugs. The study consists of 3 panels. In each panel participants will be randomly be assigned to 1 of 2 treatment sequences (AB or BA for Panel 1; CD or DC for Panel 2; and EF or FE for Panel 3). Participants will receive either single-dose darunavir 800 mg as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat 800/150 mg as tablet in each panel (under fed and fasted conditions). ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05445440 -
A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
|
Phase 1 | |
| Completed |
NCT03712540 -
An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants
|
Phase 1 | |
| Completed |
NCT03649165 -
A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT05956002 -
A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants
|
Phase 1 | |
| Completed |
NCT05539976 -
A Taste Assessment of Iberdomide and Mezigdomide in Healthy Participants
|
||
| Withdrawn |
NCT04558216 -
Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants
|
Phase 1 | |
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Completed |
NCT06097390 -
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III
|
Phase 1 | |
| Completed |
NCT05546151 -
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
|
Phase 1 | |
| Completed |
NCT05056246 -
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
|
Phase 1 | |
| Completed |
NCT04390776 -
Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.
|
Phase 1 | |
| Completed |
NCT05074459 -
A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines
|
Phase 1 | |
| Enrolling by invitation |
NCT06089109 -
Creating VIP Corps to Reduce Maternal Deaths
|
N/A | |
| Completed |
NCT05996250 -
Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects
|
N/A | |
| Completed |
NCT03278080 -
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #1
|
N/A | |
| Completed |
NCT05064800 -
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants
|
Phase 1 | |
| Completed |
NCT04471298 -
A Study of Qishenyiqi Dripping Pills in Healthy Participants
|
Phase 1 | |
| Completed |
NCT04914936 -
A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196
|
Phase 1 | |
| Completed |
NCT01681186 -
A Study of LY2940680 in Healthy Participants
|
Phase 1 | |
| Completed |
NCT02882386 -
Amino Acid Kinetics in Blood After Consuming Different Milk Protein Supplements
|
N/A |