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A single-dose, open-label, randomized crossover study to assess the bioequivalence of darunavir 800 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg, in the presence of cobicistat 150 mg, administered as either a fixed-dose combination tablet or as separate agents in healthy subjects

The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…

An open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous [14C] OZ439 microdose/800 mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered with a single dose of Cobicistat, a string CYP3A4 inhibitor, to healthy subjects in fasted state

Part 1:The purpose of Part 1 of the study is to investigate how much of the OZ439 compound is absorbed into, distributed in, and eliminated from the body (this is called pharmacokinetics) when administered orally as compared to an intravenous (iv;…

PRACTICAL study: Pharmaco-enhancement in Rheumatoid Arthritis with Cobicistat to dose Tofacitinib In Clinic Adequately Low. A within-subject sequential study.

The aim of this study is to investigate the use of cobicistat to reduce the required dose and dose frequency of tofacitinib in the treatment of RA.

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Con

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

Pharmacokinetic boosting of olaparib to improve exposure, tolerance and cost-effectiveness (PROACTIVE-study)

This study has been transitioned to CTIS with ID 2024-516414-38-00 check the CTIS register for the current data. Part APrimary objective1. To determine the equivalence of the Area-Under-the-Curve (AUC) of the reduced, boosted dose of olaparib and…

Pharmacokinetic boosting of osimertinib in patients with non-small cell lung cancer.

The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is enhanced when osimertinib is co-administered with cobicistat in patients with relatively low blood concentrations while receiving the standard…