Last reviewed · How we verify
NCT02447367
Randomized, Open-label, Single Dose, Two-way Crossover, Clinical Trial to Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 After Oral Administration in Healthy Male Volunteers
Phase 1 trial testing JLP-1207(Fasted) in LUTS in 54 participants. Completed in 1 December 2015.
1 September 2015
Quick facts
| Lead sponsor | Jeil Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 1 July 2015 |
| Primary completion | 1 September 2015 |
| Estimated completion | 1 December 2015 |
Drugs / interventions tested
- JLP-1207(Fasted) — full drug profile →
- JLP-1207(Fed) — full drug profile →
Conditions studied
- LUTS — all drugs for LUTS →
- Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
- Overactive Bladder — all drugs for Overactive Bladder →
Sponsor
Jeil Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 19 to 45, male only, with LUTS or Benign Prostatic Hyperplasia. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
AUClast, Cmax, AUCinf
Time frame: 192 hours
Sponsor's own description
The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.
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 NCT02447367
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Jeil Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07115706 — JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive GERD · not yet recruiting
- NCT06952855 — Observationa Study is a Prospective and Multi-institutional Observational Study. · completed
- NCT06431399 — To Evaluate the Safety, Pharmacokinetic Characteristics and the Effect of Food After Administration of JLP-2004 · Phase 1 · recruiting
- NCT06169059 — To Evaluate the Safety and Pharmacokinetic Characteristics After Multiple Administration of JC-013 and JLP-2004 · Phase 1 · completed
- NCT06165965 — To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JT-001, JT-002 and JLP-2008 · Phase 1 · completed
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 NCT02447367 (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 Jeil Pharmaceutical Co., Ltd.
- Last refreshed: 23 June 2016
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/NCT02447367.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing