Trial Outcomes & Findings for Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers (NCT NCT01734902)
NCT ID: NCT01734902
Last Updated: 2019-04-23
Results Overview
Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.
COMPLETED
PHASE1
30 participants
Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.
2019-04-23
Participant Flow
Randomised, single-dose, open-label, two-way crossover trial in healthy volunteers to investigate and compare the relative bioavailability of two formulations of hyoscine butylbromide administered orally as drops (T: test treatment) or as sugar-coated Buscopan® tablets(R: reference treatment).
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be randomized to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)
Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
|
Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)
Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
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|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)
Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
|
Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)
Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
|
|---|---|---|
|
Overall Study
Other than listed
|
0
|
2
|
Baseline Characteristics
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Baseline characteristics by cohort
| Measure |
Buscopan® Tablet (R)/Hyoscine Butylbromide Drops (T)
n=14 Participants
Participants administered orally in the morning on Day 1 of period 1 with single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan®, followed by 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
|
Hyoscine Butylbromide Drops (T)/Buscopan® Tablet (R)
n=16 Participants
Participants administered orally in the morning on Day 1 of period 1 with 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) orally, followed by single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® in the morning on Day 1 of period 2, each treatment with 240 mL water. Both treatment periods were separated by a wash-out period of at least 7 days.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
38.1 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
37.8 Years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
37.9 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.Population: Descriptive statistics is based on treated set (TS) and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)
Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.
Outcome measures
| Measure |
Hyoscine Butylbromide Drops (T)
n=28 Participants
Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.
|
Buscopan® Tablet (R)
n=28 Participants
Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.
|
|---|---|---|
|
Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)
|
70.3 Picogram/millilitre [pg/mL]
Geometric Coefficient of Variation 140.0
|
77.1 Picogram/millilitre [pg/mL]
Geometric Coefficient of Variation 167.0
|
PRIMARY outcome
Timeframe: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.Population: Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)
AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point
Outcome measures
| Measure |
Hyoscine Butylbromide Drops (T)
n=28 Participants
Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.
|
Buscopan® Tablet (R)
n=28 Participants
Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
564.0 Picogram*hour/millilitre [pg*h/mL]
Geometric Coefficient of Variation 131.0
|
608.0 Picogram*hour/millilitre [pg*h/mL]
Geometric Coefficient of Variation 139.0
|
SECONDARY outcome
Timeframe: Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.Population: Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)
AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity
Outcome measures
| Measure |
Hyoscine Butylbromide Drops (T)
n=28 Participants
Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.
|
Buscopan® Tablet (R)
n=28 Participants
Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.
|
|---|---|---|
|
Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )
|
623.0 Picogram*hour/millilitre [pg*h/mL]
Geometric Coefficient of Variation 122.0
|
668.0 Picogram*hour/millilitre [pg*h/mL]
Geometric Coefficient of Variation 125.0
|
Adverse Events
Hyoscine Butylbromide Drops (T)
Buscopan® Tablet (R)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hyoscine Butylbromide Drops (T)
n=30 participants at risk
Participants administered orally single dose of 20 mg hyoscine butylbromide drops with dose strength of 2 millilitre (mL) with 240 mL water in the morning on Day 1 of period 1 or period 2.
|
Buscopan® Tablet (R)
n=28 participants at risk
Participants administered orally single dose of 2 sugar-coated tablets of 10 milligram (20 mg) of Buscopan® with 240 mL water in the morning on Day 1 of period 1 or period 2.
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|---|---|---|
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Gastrointestinal disorders
Nausea
|
3.3%
1/30 • From the first dose of trial medication until 7 days after the end of treatment period, upto 9 days.
|
7.1%
2/28 • From the first dose of trial medication until 7 days after the end of treatment period, upto 9 days.
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • From the first dose of trial medication until 7 days after the end of treatment period, upto 9 days.
|
3.6%
1/28 • From the first dose of trial medication until 7 days after the end of treatment period, upto 9 days.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place