Clinical trial NCT02036775
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-03-01; Completion date: 2014-05-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To characterise pharmacokinetics and assess the relative bioavailability of two new oral formulations of ambroxol hydrochloride as Lasolvan® prolonged-release hard capsules 75 mg and Lasolvan® effervescent tablets 60 mg compared to Lasolvan® tablets 30 mg

Detailed description:

Arms: arm 1: Treatment 1, Washout 6 days, Reference product, Washout 6 days, Treatment 2 arm 2: Treatment 2, Washout period 6 days, Treatment 1, Washout 6 days, Reference product arm 3: Reference product, Washout 6 days, Treatment 2, Washout 6 days, Treatment 1 arm 4: Treatment 2, Washout 6 days, Reference product, Washout 6 days, Treatment 1 arm 5: Reference product, Washout 6 days, Treatment 1, Washout 6 days, Treatment 2 arm 6: Treatment 1, Washout 6 days, Treatment 2, Washout 6 days, Reference product
Interventions: intervention 1: Lasolvan tablet intervention 2: Lasolvan tablet intervention 3: Lasolvan tablet intervention 4: Lasolvan tablet intervention 5: Lasolvan effervescent tablet intervention 6: Lasolvan effervescent tablet intervention 7: Lasolvan effervescent tablet intervention 8: Lasolvan prolonged-release hard capsule intervention 9: Lasolvan prolonged-release hard capsule intervention 10: Lasolvan prolonged-released capsules intervention 11: Lasolvan tablet intervention 12: Lasolvan tablet intervention 13: Lasolvan prolonged-release hard capsule intervention 14: Lasolvan effervescent tablet intervention 15: Lasolvan prolonged-release hard capsule intervention 16: Lasolvan prolonged-release hard capsule intervention 17: Lasolvan effervescent tablet intervention 18: Lasolvan effervescent tablet
Intervention descriptions: intervention 1: One Lasolvan tablet 30 mg twice daily for 5 days. intervention 2: One Lasolvan tablet 30 mg twice daily for 5 days. intervention 3: One Lasolvan tablet 30 mg twice daily for 5 days. intervention 4: One Lasolvan tablet 30 mg twice daily for 5 days. intervention 5: One-half Lasolvan effervescent tablet 60mg twice daily for 5 days. intervention 6: One-half Lasolvan effervescent tablet 60mg twice daily for 5 days. intervention 7: One-half Lasolvan effervescent tablet 60mg twice daily for 5 days. intervention 8: One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days intervention 9: One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days intervention 10: One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days intervention 11: One Lasolvan tablet 30 mg twice daily for 5 days. intervention 12: One Lasolvan tablet 30 mg twice daily for 5 days. intervention 13: One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days intervention 14: One-half Lasolvan effervescent tablet 60mg twice daily for 5 days. intervention 15: One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days intervention 16: One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days intervention 17: One-half Lasolvan effervescent tablet 60mg twice daily for 5 days. intervention 18: One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.

Protocol documents: