Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02572609
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Mucosolvan ® adult syrup Mucosolvan ® adult syrup - Ambroxol hydrochloride soft pastille Ambroxol hydrochloride soft pastille -
- Primary Outcome Measures
Name Time Method Cmax 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h Maximum plasma concentration achieved
AUC0-t 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ).
- Secondary Outcome Measures
Name Time Method