Phase 1
Completed N=34
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT02417844 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Maximum Measured Concentration (Cmax) — 8826; 8856 pg/mL
Summary
Two tamsulosin HClformulations will be tested in fed state
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 | — |
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. Informational only — not medical advice.