Phase 1
Completed N=34
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Prostatic Hyperplasia
Source: ClinicalTrials.gov NCT02417831 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Cmax — 21700; 20520 pg/mL
Summary
A bio-equivalence of 2 different capsule formulations in fasted subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
21700; 20520 | — |
| PRIMARY AUC0-tz |
241500; 238200 | — |
| PRIMARY (AUC0-inf) |
248200; 244700 | — |
| SECONDARY Tmax |
5.004; 5.006 | — |
| SECONDARY λz |
0.05; 0.05 | — |
| SECONDARY t1/2 |
13.10; 13.52 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02417831). 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.