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The Drug Interaction of DWP16001 and DWC202010 After Oral Administration in Healthy Adults

NCT ID: NCT05321732

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-08-31

Brief Summary

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This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.

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Detailed Description

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The study design is a randomized, open-label, multiple-dose, crossover clinical trial. The patients were randomly assigned to each group. Primary endpoint was Cmax,ss and AUCtau,ss of DWP16001 and DWC202010. Secondary endpoints were Cmax,ss, Tmax,ss, t1/2, CLss/F, fluctuation of DWP16001 and DWC202010, and Cmax,ss, Cmin,ss, AUCtau,ss, Tmax,ss, and metabolic ratio of DWP16001 metabolites(M1).

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention: DWP16001 A mg

Group Type EXPERIMENTAL

DWP16001

Intervention Type DRUG

DWP16001 A mg

Intervention: DWC202010 B mg

Group Type EXPERIMENTAL

DWP202010

Intervention Type DRUG

DWP202010 B mg

Intervention: DWP16001 A mg + DWC202010 B mg

Group Type EXPERIMENTAL

DWP16001

Intervention Type DRUG

DWP16001 A mg

DWP202010

Intervention Type DRUG

DWP202010 B mg

Interventions

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DWP16001

DWP16001 A mg

Intervention Type DRUG

DWP202010

DWP202010 B mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Yoon S, Park MS, Jin BH, Shin H, Na J, Huh W, Kim CO. Pharmacokinetic and pharmacodynamic interaction of DWP16001, a sodium-glucose cotransporter-2 inhibitor, with phentermine in healthy subjects. Expert Opin Drug Metab Toxicol. 2023 Jul-Dec;19(7):479-485. doi: 10.1080/17425255.2023.2249397. Epub 2023 Aug 25.

Reference Type DERIVED
PMID: 37593838 (View on PubMed)

Other Identifiers

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DW_DWP306001101

Identifier Type: -

Identifier Source: org_study_id

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