Healthy Clinical Trial
Official title:
Randomised Single Dose 3 Way Crossover Single Blind Study to Evaluate the Pharmacokinetic Dose Proportionality, Compare the Bioavailability and Safety of Clonidine Mucoadhesive Buccal Tablets (MBT) With Catapres in Normal Healthy Volunteers
The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy subjects.
A single blind, randomised, 3-period, 3-sequence single-dose crossover study to determine
the pharmacokinetic dose proportionality of Clonidine MBT 50 μg and Clonidine MBT 100 μg and
comparative bioavailability of clonidine from the Reference drug, Catapres® 100 μg oral
tablets following single dose administration in healthy male and female subjects.
36 subjects will be randomised for 30 to complete the study. The study will comprise of 3
Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose).
Study drug will be administered on the morning of Day 1. Pharmacokinetic (PK) blood samples
will be collected for each of three treatment periods. Safety will be evaluated at specified
times throughout the study. There will be at least 7 days between dose administrations.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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