Bioequivalence of a New Asasantin Capsule Formulation (Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Compared to the Commercially Available Asasantin Capsule Formulation (Aggrenox®; Extended Release Combination 200 mg Dipyridamole/25 mg ASA) Following Multiple Oral Administration at Steady State After a run-in Phase (Persantine ER BID for 2 Days Each: 25 mg, 50 mg, 100 mg, 150 mg [Persantine®]; 200 mg Dipyridamole/25 mg ASA [Asasantin ER])- an Open Label, Randomized, Multiple-dose, Two-way Crossover, Change-over Study in Healthy Male and Female Volunteers

NCT02273531 Phase 1 COMPLETED

Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2004-01

Conditions

• Healthy

Interventions

• Asasantin ER, new formulation
• Asasantin ER, present commercial formulation

Primary outcomes

• Area under the concentration-time curve of dipyridamole in plasma over one dosing interval at steady state (AUCτ,ss) — up to 17 days
• Maximum measured concentration of dipyridamole in plasma at steady state (Cmax,ss) — up to 17 days