NCT03364985 is a Phase 1 clinical trial of DWP16001 in Healthy, sponsored by Daewoong Pharmaceutical Co. LTD..

Who is sponsoring NCT03364985?

NCT03364985 is sponsored by Daewoong Pharmaceutical Co. LTD..

What drugs are being tested in NCT03364985?

Interventions in NCT03364985: DWP16001, Placebo, Dapagliflozin.

Is NCT03364985 still recruiting?

NCT03364985 is currently completed. Last updated 21 August 2019.

Last reviewed 2019-08-21 · How we verify

NCT03364985

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers

Completed Phase 1 Last updated 21 August 2019

What this trial tests

Phase 1 trial testing DWP16001 in Healthy in 123 participants. Completed in 30 July 2019.

Timeline

3 December 2017

Primary endpoint
21 May 2019

30 July 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	treatment
Enrollment	123
Start date	3 December 2017
Primary completion	21 May 2019
Estimated completion	30 July 2019
Sites	1 location across South Korea

Drugs / interventions tested

DWP16001 — full drug profile →
Placebo
Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Daewoong Pharmaceutical Co. LTD. — full company profile →

Who can join

Adults 19 to 50, male only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacokinetics and Tissue Distribution of Enavogliflozin in Mice and Rats.
Pang M, Jeon SY, Choi MK, Jeon JH, et al · · 2022 · cited 12× · PMID 35745783 · DOI 10.3390/pharmaceutics14061210
Physiologically Based Pharmacokinetic Modelling to Predict Pharmacokinetics of Enavogliflozin, a Sodium-Dependent Glucose Transporter 2 Inhibitor, in Humans.
Kim MS, Song YK, Choi JS, Ji HY, et al · · 2023 · cited 8× · PMID 36986803 · DOI 10.3390/pharmaceutics15030942

Verify or expand the search:

Other trials of DWP16001

Trials testing the same drug.

NCT07213310 — Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults · Phase 1 · completed
NCT05747664 — To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function · Phase 1 · recruiting
NCT05797922 — To Evaluate the Effect of Food on the Safety and PK Characteristics of DWP16001 in Healthy Adult Volunteers · Phase 1 · unknown
NCT05737771 — To Compare the Pharmacokinetic Characteristics of the Fixed-dose Combination Compared to the Loose Combination · Phase 1 · unknown
NCT05500898 — Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults · Phase 1 · unknown

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03364985 (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: 21 August 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/NCT03364985.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing