Prostatic Hyperplasia
Conditions
Brief summary
A bio-equivalence of 2 different capsule formulations in fasted subjects
Interventions
DRUGtamsulosin capsules
DRUGtamsulosin HCl
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 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. | Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. |
| AUC0-tz | 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. | 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. |
| (AUC0-inf) | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax | 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. | Time to maximum plasma concentration |
| λz | 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. | Terminal elimination rate constant in plasma (λz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. |
| t1/2 | 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. | Apparent terminal elimination half-life of the analyte in plasma (t1/2) Geometric Coefficient of Variation (gCV) is actually inter-individual gCV. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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:
* New MR (Test): Tamsulosin 0.4mg modified release (MR) capsule.
* Registered MR (Reference) : Tamsulosin 0.4mg capsule. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 25.4 Years STANDARD_DEVIATION 5.75 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 34 | 9 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
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.
Time frame: 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.
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| New MR (Test) | (AUC0-inf) | 248200 h*pg/mL | Geometric Coefficient of Variation 49.4 |
| Registered MR (Reference) | (AUC0-inf) | 244700 h*pg/mL | Geometric Coefficient of Variation 48.9 |
90% CI: [97.81, 105.17]
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.
Time frame: 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.
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| New MR (Test) | AUC0-tz | 241500 h*pg/mL | Geometric Coefficient of Variation 48.4 |
| Registered MR (Reference) | AUC0-tz | 238200 h*pg/mL | Geometric Coefficient of Variation 48 |
90% CI: [97.71, 105.23]
Primary
Cmax
Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| New MR (Test) | Cmax | 21700 pg/mL | Geometric Coefficient of Variation 37.8 |
| Registered MR (Reference) | Cmax | 20520 pg/mL | Geometric Coefficient of Variation 36.7 |
90% CI: [99.81, 112.08]
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.
Time frame: 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.
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| New MR (Test) | t1/2 | 13.10 Hours | Geometric Coefficient of Variation 28.4 |
| Registered MR (Reference) | t1/2 | 13.52 Hours | Geometric Coefficient of Variation 24.1 |
Secondary
Tmax
Time to maximum plasma concentration
Time frame: 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.
Population: PK set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| New MR (Test) | Tmax | 5.004 Hours |
| Registered MR (Reference) | Tmax | 5.006 Hours |
Secondary
λz
Terminal elimination rate constant in plasma (λz). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Time frame: 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.
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| New MR (Test) | λz | 0.05 1/hours | Geometric Coefficient of Variation 28.4 |
| Registered MR (Reference) | λz | 0.05 1/hours | Geometric Coefficient of Variation 24.1 |