TMC114-TiDP29-C169: Bioavailability and Pharmacokinetics Trial Comparing Darunavir Pediatric Suspension Formulation to Current Darunavir Tablet
The purpose of this study is to evaluate in healthy volunteers how much and how fast the new suspension compared to the commercial darunavir tablet, given in combination with low-dose ritonavir, are absorbed into the body (called the relative oral bioavailability).
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-label, Randomized, Crossover Trial in Healthy Subjects Receiving DRV Combined With RTV Low Dose to Compare the Oral Bioavailability of DRV Suspension to That of DRV 300 mg Tablet Under Fasted and Fed Conditions, and to Assess Multiple Dose Pharmacokinetics of the DRV Suspension|
- Part 1: plasma concentrations of DRV and RTV. Time frame day 3: predose and up to 12h, then at 24, 48, 72h. Part 2: plasma concentrations of DRV and RTV. Time frame: predose day 1 and day 5-6; day 7 predose and up to 12h, then at 24, 48, 72h.
- Short term safety and tolerability of DRV, formulated as suspension or as tablet, in the presence of low-dose RTV.
|Study Start Date:||April 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
The objectives of this trial are in Part 1 to compare the rate and extent of absorption of a single oral dose of 600 mg darunavir (DRV) administered as the suspension formulation F051 (under fed and fasted conditions) to that of the commercial tablet formulation F016 (under fed conditions), in the presence of low-dose ritonavir in healthy volunteers; and to compare the rate and extent of absorption of a single oral dose of 600 mg DRV administered as the suspension formulation F051 under fed conditions to that under fasted conditions, in the presence of low-dose ritonavir in healthy volunteers. In Part 2 we want to assess multiple dose pharmacokinetics of DRV administered as the suspension formulation F051 (under fed or fasted conditions, based on the results of Part 1), in the presence of low-dose ritonavir in healthy volunteers. The short-term safety and tolerability of DRV will be evaluated following administration of 3 single oral doses of 600 mg (formulated as suspension and as tablet) and following administration of multiple oral doses (formulated as suspension), all in presence of low-dose ritonavir in healthy volunteers Part 1: during 3 sessions volunteers will orally receive 3 single doses of 600 mg darunavir (DRV): 2 tablets of 300 mg and 6 ml of suspension under fed conditions and 6 mL of suspension (100 mg/mL) under fasted conditions on Day 3. Part 2: subjects will receive DRV suspension, twice daily from Day 1 to 6, with an additional morning dose on Day 7. In Part I rtv 100 mg will be coadministered twice daily from Day 1 to Day 5 and in Part 2 from Day 1 to Day 9.