Trial Outcomes & Findings for Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride (NCT NCT02572609)

Results Overview

Maximum plasma concentration achieved

Recruitment status

COMPLETED

Study phase

PHASE1

Primary outcome timeframe

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

Results posted on

2015-12-31

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Period 1: Treatment Period 1 + Washout STARTED	18	18
Period 1: Treatment Period 1 + Washout COMPLETED	18	18
Period 1: Treatment Period 1 + Washout NOT COMPLETED	0	0
Period 2: Treatment Period 2 STARTED	18	18
Period 2: Treatment Period 2 COMPLETED	18	18
Period 2: Treatment Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence: TR n=18 Participants 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	Sequence: RT n=18 Participants 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	Total n=36 Participants Total of all reporting groups
Age, Continuous	29.39 Years STANDARD_DEVIATION 5.80 • n=5 Participants	31.22 Years STANDARD_DEVIATION 7.30 • n=7 Participants	30.30 Years STANDARD_DEVIATION 6.60 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Maximum plasma concentration achieved

Outcome measures

Outcome measures
Measure	Mucosolvan ® Adult Syrup n=18 Participants 2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).	Ambroxol Hydrochloride Soft Pastille n=18 Participants 01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
Cmax	31.27 ng/mL Geometric Coefficient of Variation 30.38	35.50 ng/mL Geometric Coefficient of Variation 28.62

PRIMARY outcome

Timeframe: 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

Population: PK set

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).

Outcome measures

Outcome measures
Measure	Mucosolvan ® Adult Syrup n=18 Participants 2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).	Ambroxol Hydrochloride Soft Pastille n=18 Participants 01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
AUC0-t	256.66 ng.h/mL Geometric Coefficient of Variation 33.36	307.00 ng.h/mL Geometric Coefficient of Variation 28.97

Adverse Events

Mucosolvan® Adult Syrup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ambroxol Hydrochloride Soft Pastille

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER