Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers

Phase 1 Completed 36 enrolled Valerio Therapeutics Simbec Research · collab

RandomizedCrossoverSingle-blindTreatment

Summary

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.

Timeline

Start: 2015-09
Primary completion: 2015-12
Completion: 2016-04

Publications

Vasseur B, Dufour A, Houdas L, Goodwin H, Harries K, Emul NY, Hutchings S. Comparison of the Systemic and Local Pharmacokinetics of Clonidine Mucoadhesive Buccal Tablets with Reference Clonidine Oral Tablets in Healthy Volunteers: An Open-Label Randomised Cross-Over Trial. Adv Ther. 2017 Aug;34(8):2022-2032. doi: 10.1007/s12325-017-0585-9. Epub 2017 Jul 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clonidine	Other / unclassified	50 ug	Other
Subject	Clonidine	Other / unclassified	100 ug	Other

Indications

No indication recorded.