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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucosolvan ® adult syrup | Experimental |
| |
| Ambroxol hydrochloride soft pastille | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambroxol hydrochloride soft pastille | Drug |
| ||
| Mucosolvan ® adult syrup |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration achieved | 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 |
| AUC0-t | 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). | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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The crossover design 2x2 was used in the study. This is a conventional nonreplicated design with two formulations, two periods, two sequences (RT and TR) where each individual is randomly allocated in one of these sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence: TR | 01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2. Washout period: 7 days |
| FG001 | Sequence: RT | 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2. Washout period: 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Treatment Period 1 + Washout |
| |||||||||||||
| Period 2: Treatment Period 2 |
|
Treated set (TS): 36 subjects took 1 dose of reference product and 1 dose of test product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence: TR | 01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2. Washout period: 7 days |
| BG001 | Sequence: RT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | Maximum plasma concentration achieved | The pharmacokinetic set (PK Set): 36 subjects provided 1 evaluable value of reference product and 1 evaluable value of test product for the primary PK endpoints (Cmax and AUC0-t) without important protocol violations with respect to the statistical evaluation of PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
|
From first drug administration until 48 hours after last drug administration, upto 08 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mucosolvan® Adult Syrup |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Drug |
|
| NOT COMPLETED |
|
2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2. Washout period: 7 days |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product). |
|
|
|
| Primary | AUC0-t | 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). | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng.h/mL | 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 |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Ambroxol Hydrochloride Soft Pastille | 0 | 36 | 0 | 36 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.