At a glance
ClinicalIndex Comparison RecordPhase 1Completed
Drug / intervention
Ambroxol hydrochloride soft pastille +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride
In Brief
A Phase 1 clinical trial evaluating Ambroxol hydrochloride soft pastille and Mucosolvan ® adult syrup for Healthy. Completed.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
Primary CompletionDec 2011
First PostedOct 2015
TodayJul 2026
First PostedOct 9, 2015
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.7 years ago
Interventions
Ambroxol hydrochloride soft pastilledrug
Mucosolvan ® adult syrupdrug