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NCT02494349
Clinical Trial to Investigate and Compare the Pharmacokinetic Characteristics and Safety/Tolerability After Single Administration of JLP-1207 and Soifenacin/Tamsulosin in Healthy Male Volunteers.
Phase 1 trial testing JLP-1207 in LUTS(Lower Urinary Tract Symptoms) in 54 participants. Completed in 1 December 2015.
1 November 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 August 2015 |
| Primary completion | 1 November 2015 |
| Estimated completion | 1 December 2015 |
Drugs / interventions tested
- JLP-1207 — full drug profile →
- Solifenacin 5mg+Tamsulosin 0.2mg — full drug profile →
Conditions studied
- LUTS(Lower Urinary Tract Symptoms) — all drugs for LUTS(Lower Urinary Tract Symptoms) →
- 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(Lower Urinary Tract Symptoms) 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
Time frame: 192 hours
Sponsor's own description
The purpose of this study is to investigate and compare the pharmacokinetic characteristics and safety/tolerability between JLP-1207(Solifenacin/Tamsulosin 5mg/0.2mg)and co-administration of Solifenacin and Tamsulosin 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 NCT02494349
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for LUTS(Lower Urinary Tract Symptoms)
Currently open trials in the same condition.
- NCT05401032 — Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH. · Phase 2 · recruiting
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 NCT02494349 (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/NCT02494349.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing