CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 141 enrolled
Drug / intervention
Dasatinib as tablets +2 moredrug
Likely dose
Dasatinib as tablets 240 mLfrom 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.

Search/NCT01392703
NCT01392703Phase 1Completed
CompareCT.gov

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

Bristol-Myers Squibb·interventional·Posted Jul 12, 2011·Updated Feb 11, 2013

In Brief

A Phase 1 clinical trial evaluating Dasatinib as tablets, Dasatinib as liquid, and 1 other intervention for Pharmacokinetic Study in Healthy Participants. Completed, enrolled 141 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharmacokinetic Study in Healthy Participants
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2011
Enrollment StartJul 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.0 years ago

Interventions

Dasatinib as tabletsdrug

2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day

Dasatinib as liquiddrug

100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day

Dasatinib as dispersed tabletsdrug

2 50-mg dispersed tablets in 30 mL of 100% orange juice followed by 15 mL of orange juice plus 195 mL noncarbonated, nonrefrigerated water. Liquid (oral solution), single dose, 1 day.