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Two tamsulosin HClformulations will be tested in fed state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin HCl | Active Comparator |
| |
| Tamsulosin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamsulosin (Astellas) | Drug |
| ||
| Tamsulosin HCL |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of analyte in plasma (Cmax) | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (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) | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf) | Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) | Time from last dosing to the maximum plasma concentration (tmax). | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Terminal Elimination Rate Constant (λz) |
Not provided
Inclusion criteria:
Health male volunteers 18 years and older
Exclusion criteria:
History of hypersensitivity or allergy to IMP or its excipients or any related medication
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
Not provided
Each treatment was administered after consumption of a high-fat, high-calorie breakfast.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin HCl (Test) / Flomax Relief (Reference) | Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule followed by oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules). |
| FG001 | Flomax Relief (Reference) / Tamsulosin HCl (Test) | Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules) followed by oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 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 | Maximum Measured Concentration (Cmax) | Maximum measured concentration of analyte in plasma (Cmax) | Pharmacokinetic (PK) set which included all subjects who had evaluable PK data for both treatment periods. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
|
Up to 72 hours
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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 | Tamsulosin HCl (Test) | Oral administration of Tamsulosin hydrochloride (HCl) 0.4mg modified release (MR) capsule. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 18.1 | Systematic Assessment |
Not provided
| 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 |
Not provided
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|
Terminal elimination rate constant in plasma (λz) |
| Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Apparent Terminal Elimination Half-life (t1/2) | Apparent terminal elimination half-life of the analyte in plasma (t1/2) | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Primary | Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (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) | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
|
| Primary | Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf) | Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) | Time from last dosing to the maximum plasma concentration (tmax). | PK set | Posted | Median | Full Range | Hours | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Secondary | Terminal Elimination Rate Constant (λz) | Terminal elimination rate constant in plasma (λz) | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| Secondary | Apparent Terminal Elimination Half-life (t1/2) | Apparent terminal elimination half-life of the analyte in plasma (t1/2) | PK set | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration |
|
|
|
| 0 |
| 34 |
| 5 |
| 34 |
| EG001 | Flomax Relief (Reference) | Oral administration of Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules). | 0 | 34 | 1 | 34 |
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 |