Last reviewed · How we verify
NCT03574415
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Japanese, Caucasian and Korean
Phase 1 trial testing DWP14012 in Healthy Volunteers in 80 participants. Completed in 23 January 2019.
18 January 2019
Quick facts
| Lead sponsor | Daewoong Pharmaceutical Co. LTD. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 80 |
| Start date | 1 November 2018 |
| Primary completion | 18 January 2019 |
| Estimated completion | 23 January 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- DWP14012 — full drug profile →
- Placebo
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Daewoong Pharmaceutical Co. LTD. — full company profile →
Who can join
Adults 19 to 50, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and tolerability of single and multiple ascending oral doses of DWP14012 in healthy Japanese, Caucasian and Korean subjects
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Development of Physiologically Based Pharmacokinetic Model for Orally Administered Fexuprazan in Humans.
Jeong YS, Kim MS, Lee N, Lee A, et al · · 2021 · cited 19× · PMID 34072547 · DOI 10.3390/pharmaceutics13060813
Verify or expand the search:
- PubMed search for NCT03574415
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DWP14012
Trials testing the same drug.
- NCT05812404 — Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 in Healthy Subjects · Phase 1 · unknown
- NCT05574374 — Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects · Phase 1 · completed
- NCT05304845 — Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects · Phase 1 · completed
- NCT05813561 — The Efficacy and Safety of DWP14012 in Chinese Patients With Reflux Esophagitis · Phase 3 · completed
- NCT04888819 — Treatment Effect According to Timing of Administration of DWP14012 40 mg · NA · unknown
Other recruiting trials for Healthy Volunteers
Currently open trials in the same condition.
- NCT07504003 — Influence of Training Session Duration on Improvements in Physiological Resilience to Exercise · NA · recruiting
- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
- NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
- NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
- NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting
Other Daewoong Pharmaceutical Co. LTD. trials
Trials by the same sponsor.
- NCT07515560 — Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study · not yet recruiting
- NCT07516977 — Noseguard for Prevention of Respiratory Infections in Real-World Use · NA · not yet recruiting
- NCT07539415 — A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Hea · Phase 1 · not yet recruiting
- NCT07267221 — Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers · Phase 1 · recruiting
- NCT07256600 — PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers · 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 NCT03574415 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Daewoong Pharmaceutical Co. LTD.
- Last refreshed: 27 June 2019
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/NCT03574415.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing