A Phase I Open Label, Randomised, Single Dose, 2-way Crossover, 2-Sequence Pharmacokinetic Study on the Interaction of Colesevelam and Ciclosporin in Healthy Volunteers

NCT00692250 Phase 1 COMPLETED

This study is designed to assess any potential interaction between colesevelam and ciclosporin in healthy volunteers.

Details

Lead sponsor	Genzyme, a Sanofi Company
Phase	Phase 1
Status	COMPLETED
Enrolment	14
Start date	2007-09
Completion	2007-12

Conditions

• Healthy

Interventions

• Colesevelam hydrochloride film-coated tablets (Cholestagel)

Primary outcomes

• Bioavailability of Ciclosporin (AUC(0-t), AUC(∞) and C(max)) — 12 weeks

Countries

Netherlands