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Open-label, Randomized, 3-period, 3-treatment Crossover, Bioequivalence Study Comparing Dasatinib (BMS-354825) Liquid Formulation and the Dispersed Tablet Formulation Relative to the Reference Tablet Formulation in Health Subjects
The purpose of the study is to compare the blood levels of dasatinib in healthy participants who received tablet formulation with those of healthy participants who received liquid and tablet-dispersed formulations of the drug.
Details
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 141 |
| Start date | 2011-07 |
| Completion | 2011-09 |
Conditions
- Pharmacokinetic Study in Healthy Participants
Interventions
- Dasatinib as tablets
- Dasatinib as liquid
- Dasatinib as dispersed tablets
Primary outcomes
- Maximum Observed Concentration (Cmax) of Dasatinib — Days 1-2, Days 5-6, and Days 9-10
Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data. - Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib — Days 1-2, Days 5-6, and Days 9-10
Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data. - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib — Days 1-2, Days 5-6, and Days 9-10
Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data.
Countries
United States