Trial Outcomes & Findings for Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide. (NCT NCT02516098)
NCT ID: NCT02516098
Last Updated: 2017-04-05
Results Overview
The maximum measured concentration of hyoscine butylbromide in plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter
Results posted on
2017-04-05
Participant Flow
All subjects were screened for eligibility to participate in the trial. Subjects who meet the inclusion criteria will be considered eligible to participate in the study. Subjects who meet one or more of the exclusion criteria will not be considered eligible to participate in the study.
Participant milestones
| Measure |
REF-T
The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet.
|
T-REF
The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet.
|
|---|---|---|
|
Period 1
STARTED
|
28
|
28
|
|
Period 1
COMPLETED
|
27
|
28
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Washout After Period 1
STARTED
|
27
|
28
|
|
Washout After Period 1
COMPLETED
|
27
|
27
|
|
Washout After Period 1
NOT COMPLETED
|
0
|
1
|
|
Period 2
STARTED
|
27
|
27
|
|
Period 2
COMPLETED
|
27
|
26
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
|
Washout After Period 2
STARTED
|
27
|
26
|
|
Washout After Period 2
COMPLETED
|
27
|
26
|
|
Washout After Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
REF-T
The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet.
|
T-REF
The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet.
|
|---|---|---|
|
Period 1
Protocol Violation
|
1
|
0
|
|
Washout After Period 1
Adverse Event
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Baseline characteristics by cohort
| Measure |
REF-T
n=28 Participants
The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet.
|
T-REF
n=28 Participants
The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) followed by a washout period of 7 to 14 days.
All medications were administered as a single oral dose in the fasted state via a sugar coated tablet.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 7.17 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 3.90 • n=7 Participants
|
25.6 years
STANDARD_DEVIATION 5.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafterPopulation: All subjects who had evaluable pharmacokinetic (PK) data for at least one of the treatment periods were included in the PK population.
The maximum measured concentration of hyoscine butylbromide in plasma.
Outcome measures
| Measure |
Buscopan® (REF)
n=54 Participants
The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
|
Buscapina® (T)
n=55 Participants
The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
|
|---|---|---|
|
Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)
|
91 picogram (pg)/millilitre (mL)
Geometric Coefficient of Variation 93.4
|
80 picogram (pg)/millilitre (mL)
Geometric Coefficient of Variation 100.6
|
PRIMARY outcome
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafterPopulation: PK population
Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).
Outcome measures
| Measure |
Buscopan® (REF)
n=52 Participants
The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
|
Buscapina® (T)
n=55 Participants
The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
|
|---|---|---|
|
AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)
|
807 hour (h)*pg/mL
Geometric Coefficient of Variation 89.3
|
725 hour (h)*pg/mL
Geometric Coefficient of Variation 89.1
|
SECONDARY outcome
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafterPopulation: PK population
The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Outcome measures
| Measure |
Buscopan® (REF)
n=52 Participants
The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
|
Buscapina® (T)
n=55 Participants
The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).
|
847 h*pg/mL
Geometric Coefficient of Variation 86.6
|
760 h*pg/mL
Geometric Coefficient of Variation 88.5
|
SECONDARY outcome
Timeframe: Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafterPopulation: PK population
Area under the concentration-time curve of hyoscine butylbromide to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®). This was calculated both for test and reference products.
Outcome measures
| Measure |
Buscopan® (REF)
n=52 Participants
The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
|
Buscapina® (T)
n=54 Participants
The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2\*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
|
|---|---|---|
|
Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)
|
187 h*pg/mL
Geometric Coefficient of Variation 104.0
|
170 h*pg/mL
Geometric Coefficient of Variation 121.8
|
Adverse Events
Buscopan® (REF)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buscapina® (T)
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 Other - 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 right.
- Publication restrictions are in place
Restriction type: OTHER