drugset
drugset / Trial / NCT02572609

Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride

NCT02572609 ↗

Phase 1 Completed Boehringer Ingelheim
CrossoverOpen-labelTreatment

Summary

to evaluate the bioavailability of ambroxol hydrochloride soft pastilles (test formulation), manufactured by Bolder Arzneimittel GmbH \& Co. KG to Boehringer Ingelheim compared to ambroxol hydrochloride syrup (Mucosolvan® adult syrup), manufactured by Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda.

Timeline

Start
2011-11
Primary completion
2011-12
Completion
2011-12

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); Mucosolvan ® Adult Syrup vs Ambroxol Hydrochloride Soft Pastille; p = 0.0082; T/R Ratio 113.56 (90% CI 106.48 to 121.10); Anderson-Hauck procedure NCT02572609 ↗

registry analysis (non-inferiority or equivalence test); Mucosolvan ® Adult Syrup vs Ambroxol Hydrochloride Soft Pastille; p = 0.0438; T/R Ratio 119.61 (90% CI 114.65 to 124.79); Anderson-Hauck procedure NCT02572609 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ambroxol Small molecule — —

Indications

No indication recorded.