Phase 1
N=34
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT02417844 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Maximum Measured Concentration (Cmax) — 8826; 8856 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- tamsulosin (Astellas) (Drug); Tamsulosin HCL (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Measured Concentration (Cmax) |
8826; 8856 | — |
| PRIMARY Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) |
164700; 165400 | — |
| PRIMARY Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf) |
170100; 171000 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
7.51; 8.00 | — |
| SECONDARY Terminal Elimination Rate Constant (λz) |
0.05; 0.05 | — |
| SECONDARY Apparent Terminal Elimination Half-life (t1/2) |
13.16; 13.21 | — |
Summary
Two tamsulosin HClformulations will be tested in fed state
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02417844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.