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NCT02138773
A Randomized, Single Dose, Open-label, Cross-over Study on Bioequivalence of Two Formulations of Tamsulosin Hydrochloride Prolonged Release Capsule (Tamsulosin Pellet From Meppel Plant and Nishine Plant) Under Fed and Fasted Conditions in Chinese Healthy Male Subjects
Phase 1 trial testing Tamsulosin formulation-A in Healthy in 80 participants. Completed in 1 July 2014.
1 July 2014
Quick facts
| Lead sponsor | Astellas Pharma China, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Enrollment | 80 |
| Start date | 1 April 2014 |
| Primary completion | 1 July 2014 |
| Estimated completion | 1 July 2014 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tamsulosin formulation-A — full drug profile →
- Tamsulosin formulation-B — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
- Pharmacokinetics of Tamsulosin Hydrochloride — all drugs for Pharmacokinetics of Tamsulosin Hydrochloride →
Sponsor
Astellas Pharma China, Inc. — full company profile →
Who can join
Adults 18 to 40, male only, with Healthy or Pharmacokinetics of Tamsulosin Hydrochloride. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pharmacokinetic parameter of tamsulosin (AUC0-t)
Time frame: up to 72 hr after administration
AUC0-t will be calculated according to the linear trapezoidal rule. -
Pharmacokinetic parameter of tamsulosin (Cmax)
Time frame: up to 72 hr after administration
Sponsor's own description
The purpose of this study is to investigate the relative bioavailability of two types of prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The safety of tamsulosin formulation is also compared.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02138773
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Astellas Pharma China, Inc. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02138773 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma China, Inc.
- Last refreshed: 14 July 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02138773.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing