Phase 1
N=34
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT02417831 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Cmax — 21700; 20520 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- tamsulosin capsules (Drug); tamsulosin HCl (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2015
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 | — |
Summary
A bio-equivalence of 2 different capsule formulations in fasted subjects
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.