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A bio-equivalence of 2 different capsule formulations in fasted subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamsulosin capsules | Active Comparator |
| |
| tamsulosin HCl capsules | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamsulosin capsules | Drug |
| ||
| tamsulosin HCl |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
| AUC0-tz | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
| (AUC0-inf) | Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to maximum plasma concentration | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
| λz |
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Inclusion criteria:
Healthy male volunteers 18 years and older
Exclusion criteria:
History of hypersensitivity or allergy to the IPM or its excipients or any related medication
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | New MR (Test) / Registered MR (Reference) | Oral administration of tamsulosin new 0.4mg modified release (MR) capsule followed by oral administration of tamsulosin registered 0.4mg MR capsule in the fasted state after an overnight fast of at least 10 hours. Treatment periods were separated by a wash-out period of 07 days. |
| FG001 | Registered MR (Reference) / New MR (Test) | Oral administration of tamsulosin registered 0.4mg MR capsule followed by oral administration of tamsulosin new 0.4mg MR capsule in the fasted state after an overnight fast of at least 10 hours. Treatment periods were separated by a wash-out period of 07 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Treatment Period 1 + Washout |
| |||||||||||||
| Period 2: Treatment Period 2 + Washout |
|
Treated set which included all subjects who received at least one dose of investigational medicinal product.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Subjects each received two treatments which were each administered orally in the fasted state after an overnight fast of at least 10 hours. and separated by a washout period of 7 days. The treatments were:
|
| 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 measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | Pharmacokinetic set (PK set): All subjects who had evaluable pharmacokinetic (PK) data for both treatment periods were included in the statistical PK analysis for the study. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
|
From drug administration until 7days thereafter for each treatment arm, upto 10 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 | New MR (Test) | Oral administration of tamsulosin new 0.4mg modified release (MR) capsule. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
Terminal elimination rate constant in plasma (λz).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
| Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
| t1/2 | Apparent terminal elimination half-life of the analyte in plasma (t1/2) Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Oral administration of tamsulosin registered 0.4mg MR capsule.
|
|
|
| Primary | AUC0-tz | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
|
|
|
|
| Primary | (AUC0-inf) | Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
|
|
|
|
| Secondary | Tmax | Time to maximum plasma concentration | PK set | Posted | Median | Full Range | Hours | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
|
|
|
| Secondary | λz | Terminal elimination rate constant in plasma (λz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hours | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
|
|
|
| Secondary | t1/2 | Apparent terminal elimination half-life of the analyte in plasma (t1/2) Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. |
|
|
|
| 0 |
| 34 |
| 6 |
| 34 |
| EG001 | Registered MR (Reference) | Oral administration of tamsulosin registered 0.4mg MR capsule. | 0 | 34 | 9 | 34 |
| Headache | Nervous system disorders | 18.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 18.1 | Systematic Assessment |
|
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.
| D052801 |
| Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |