Metabolic, Cardiovascular Clinical Trial
Official title:
A Four Way Crossover Study in Healthy Volunteers to Evaluate the Application of Stable Isotope Approach to Reduce Number of Subjects Needed for PK Studies
This will be a randomized, open-label, single dose, 4-period, period balanced, crossover
study. There will be at least 5 days between dosing in each session. The study consists of
Screening period (30 days prior to Day 1), Treatment period consisting of 4 dosing periods
(Day 1 is the dosing day and Day 2) and Follow-up period (7-14 days post-last dose).
The detailed treatment regimen will be A and B (27.5 mg total maximum dose): Single oral
dose of carvedilol 25 mg immediate release tablet and up to 2.5 mg of enriched carvedilol
powder under fasted conditions; C (33.75 mg total maximum dose): Single oral dose of
carvedilol 31.25 mg as 25 mg immediate release tablet, a 6.25 mg immediate release tablet
and up to 2.5 mg of enriched carvedilol powder under fasted conditions; D (27.5 mg total
maximum dose): Single oral dose of carvedilol 25 mg immediate release tablet and up to 2.5
mg of enriched carvedilol powder under fed conditions. Approximately 15 subjects will be
randomized to receive one of four treatment sequences (ADBC, BACD, CBDA, or DCAB).
The pharmacokinetic sampling and safety data will be collected in the Treatment period (Day
1 and 2).
n/a