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Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyoscine butylbromide SCT | Active Comparator |
| |
| Hyoscine butylbromide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyoscine butylbromide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax) | The maximum measured concentration of hyoscine butylbromide in plasma. | 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 |
| AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t) | 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞). | The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | 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 |
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Inclusion criteria:
healthy males and females, aged 18-50years, BMI 18,5-30
Exclusion criteria:
History of hypersensitivity or allergy to IMP
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Bloemfontein | Canada |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Washout After Period 1 |
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| Period 2 |
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| Washout After Period 2 |
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All subjects who received at least a single dose of the study medication were included in the safety population (safety population = 56 subjects).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax) | The maximum measured concentration of hyoscine butylbromide in plasma. | All subjects who had evaluable pharmacokinetic (PK) data for at least one of the treatment periods were included in the PK population. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram (pg)/millilitre (mL) | 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 |
|
From the first administration of study medication to up to 96 hours of completion of the last period or up to 72 hours after withdrawal/withdrawing from the study (up to 34 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 | Buscopan® (REF) | 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. |
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There was a stage 2 planned after stage 1 which was not performed as bioequivalence was concluded after completion of Stage 1.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
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| Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax) | 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. | 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 |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Buscapina® (T) |
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 |
|
|
|
| Primary | AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t) | 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). | PK population | Posted | Geometric Mean | Geometric Coefficient of Variation | hour (h)*pg/mL | 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 |
|
|
|
|
| Secondary | Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞). | The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). | PK population | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | 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 |
|
|
|
|
| Secondary | Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax) | 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. | PK population | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | 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 |
|
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Buscapina® (T) | 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 | 0 | 56 | 0 | 56 |
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.
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |