Prostatic Hyperplasia
Conditions
Brief summary
Two tamsulosin HClformulations will be tested in fed state
Interventions
DRUGtamsulosin (Astellas)
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
Health male volunteers 18 years and older
Exclusion criteria
History of hypersensitivity or allergy to IMP or its excipients or any related medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Measured Concentration (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 | Maximum measured concentration of analyte in plasma (Cmax) |
| Area Under the Concentration-time Curve 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 of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) |
| Area Under the Concentration-time Curve 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 | Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to 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 | Time from last dosing to the maximum plasma concentration (tmax). |
| Terminal Elimination Rate Constant (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 | Terminal elimination rate constant in plasma (λz) |
| Apparent Terminal Elimination Half-life (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 | Apparent terminal elimination half-life of the analyte in plasma (t1/2) |
Participant flow
Pre-assignment details
Each treatment was administered after consumption of a high-fat, high-calorie breakfast.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects each received two treatments which were each administered orally and separated by a washout period of 7 days. The treatments were:
* Flomax Relief (Reference): Flomax Relief modified release (MR) 0.4mg capsule (tamsulosin MR capsules).
* Tamsulosin hydrochloride (HCl) (Test): Tamsulosin HCl 0.4mg modified release (MR) capsule. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 24.6 Years STANDARD_DEVIATION 5.53 |
| 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 | 5 / 34 | 1 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
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).
Time frame: 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
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin HCl (Test) | Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf) | 170100 h*pg/mL | Geometric Coefficient of Variation 44.1 |
| Flomax Relief (Reference) | Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf) | 171000 h*pg/mL | Geometric Coefficient of Variation 45.2 |
90% CI: [93.9, 105.39]
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)
Time frame: 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
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin HCl (Test) | Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) | 164700 h*pg/mL | Geometric Coefficient of Variation 42.4 |
| Flomax Relief (Reference) | Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) | 165400 h*pg/mL | Geometric Coefficient of Variation 43.7 |
90% CI: [94.23, 105.24]
Primary
Maximum Measured Concentration (Cmax)
Maximum measured concentration of analyte in plasma (Cmax)
Time frame: 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
Population: Pharmacokinetic (PK) set which included all subjects who had evaluable PK data for both treatment periods.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin HCl (Test) | Maximum Measured Concentration (Cmax) | 8826 pg/mL | Geometric Coefficient of Variation 31.8 |
| Flomax Relief (Reference) | Maximum Measured Concentration (Cmax) | 8856 pg/mL | Geometric Coefficient of Variation 34 |
90% CI: [92.19, 107.74]
Secondary
Apparent Terminal Elimination Half-life (t1/2)
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Time frame: 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
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin HCl (Test) | Apparent Terminal Elimination Half-life (t1/2) | 13.16 hours | Geometric Coefficient of Variation 21.6 |
| Flomax Relief (Reference) | Apparent Terminal Elimination Half-life (t1/2) | 13.21 hours | Geometric Coefficient of Variation 21.9 |
Secondary
Terminal Elimination Rate Constant (λz)
Terminal elimination rate constant in plasma (λz)
Time frame: 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
Population: PK set
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Tamsulosin HCl (Test) | Terminal Elimination Rate Constant (λz) | 0.05 1/hour | Geometric Coefficient of Variation 21.6 |
| Flomax Relief (Reference) | Terminal Elimination Rate Constant (λz) | 0.05 1/hour | Geometric Coefficient of Variation 21.9 |
Secondary
Time to Maximum Plasma Concentration (Tmax)
Time from last dosing to the maximum plasma concentration (tmax).
Time frame: 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
Population: PK set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tamsulosin HCl (Test) | Time to Maximum Plasma Concentration (Tmax) | 7.51 Hours |
| Flomax Relief (Reference) | Time to Maximum Plasma Concentration (Tmax) | 8.00 Hours |