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NCT02581696
An Open-label, Multiple-dose, Single-arm, Phase 1 Study to Evaluate the Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers
Phase 1 trial testing Lafutidine in Peptic Ulcer in 24 participants. Completed in 1 November 2015.
1 November 2015
Quick facts
| Lead sponsor | Boryung Pharmaceutical Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 1 August 2015 |
| Primary completion | 1 November 2015 |
| Estimated completion | 1 November 2015 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Lafutidine (LAFUTIDINE) — full drug profile →
- Irsogladine maleate — full drug profile →
Conditions studied
- Peptic Ulcer — all drugs for Peptic Ulcer →
Sponsor
Boryung Pharmaceutical Co., Ltd — full company profile →
Who can join
Adults 19 to 50, any sex, with Peptic Ulcer. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Area under the plasma concentration versus time curve of Lafutidine and Irsogladine maleate
Time frame: Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)
Sponsor's own description
An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult 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 NCT02581696
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lafutidine
Trials testing the same drug.
- NCT02759224 — A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet · Phase 1 · completed
Other recruiting trials for Peptic Ulcer
Currently open trials in the same condition.
- NCT07260006 — Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Dis · NA · recruiting
- NCT06284876 — Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer · Phase 3 · recruiting
- NCT04702542 — To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children. · NA · active not recruiting
Other Boryung Pharmaceutical Co., Ltd trials
Trials by the same sponsor.
- NCT07421414 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421401 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421388 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07421375 — A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015 · Phase 1 · not yet recruiting
- NCT07373613 — A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension · Phase 2 · not yet recruiting
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 NCT02581696 (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 Boryung Pharmaceutical Co., Ltd
- Last refreshed: 3 February 2017
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/NCT02581696.
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