Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults

NCT ID: NCT06644404

Last Updated: 2024-10-16

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-26

Study Completion Date

2025-04-01

Brief Summary

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This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults

Detailed Description

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This study aims to evaluate the pharmacokinetic interactions, pharmacodynamic interactions, safety, and tolerability of DWP16001, DWC202407, and DWC202408 in healthy adults

Conditions

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Healthy

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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Enavogliflozin 0.3mg, once daily

Group Type EXPERIMENTAL

DWP16001 0.3mg

Intervention Type DRUG

1 tablet, Orally, Once daily single dose

Metformin 1,000mg, BID

Group Type EXPERIMENTAL

DWC202407 1,000mg

Intervention Type DRUG

1 tablet, Orally, Twice daily

Glimepiride 2mg, once daily

Group Type EXPERIMENTAL

DWC202408 2mg

Intervention Type DRUG

1 tablet, Orally, Once daily single dose

Interventions

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DWP16001 0.3mg

1 tablet, Orally, Once daily single dose

Intervention Type DRUG

DWC202407 1,000mg

1 tablet, Orally, Twice daily

Intervention Type DRUG

DWC202408 2mg

1 tablet, Orally, Once daily single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy adult volunteers aged 19 to 50 years at the time of screening.
2. Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.
3. Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
4. Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 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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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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DaYe Jung

Role: CONTACT

+82-2-550-8317

Facility Contacts

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SeungHwan Lee

Role: primary

+82-2-550-8317

Other Identifiers

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DW_DWP16001112

Identifier Type: -

Identifier Source: org_study_id

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