Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: DWP16001

• Registration Number: NCT07213310
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

Drug-Drug Interaction Study to Evaluate the Effect of DWC202511 or DWC202512 With DWP16001 in Healthy Adults

Detailed Description

A phase 1, open-label, fixed-sequence, drug-drug interaction study to evaluate the effect of DWC202511 or DWC202512 on the pharmacokinetics of DWP16001 and its metabolite in healthy adult subjects

Study Timeline

• Study First Submitted: 2025-07-29
• Status Verified: 2025-08
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Study Start: 2025-11-01
• Primary Completion: 2026-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy adult volunteers aged 19 to 50 years at the time of screening.
• 50.0 kg ≤ Body weight ≤ 90.0 kg and 18.5 ≤ Body Mass Index (BMI) ≤ 29.9 kg/m² at the time of screening.
• Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study, etc.

Exclusion Criteria

• Currect or history of clinically significant hepatic, renal, kidney, nervous, immune, respiratory, gastrointestinal, endocrine, hematologic/oncologic conditions, cardiovascular, genitourinary, psychiatric, or sexual disorders.
• History of gastrointestinal diseases (e.g., Crohn's disease, ulcers, gastritis, gastric spasms, gastroesophageal reflux disease) or surgeries (excluding simple appendectomy or hernia repair) that may affect the safety, pharmacokinetics, or pharmacodynamics of the investigational product.
• Current or history of gastrointestinal disorders or prior gastrointestinal surgery (except appendectomy or hernia repair) that may affect safety or PK/PD assessment of the investigational product.

Current or history of urinary tract infection or genital fungal infection.

• Current or history of metabolic acidosis, such as diabetic ketoacidosis.
• Genetic disorders including galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	DWP16001	Participants will received the following drugs in a fixed-sequence Drug: DWP16001 Drug: DWC202511 Drug: DWC202512

Primary Outcome Measures

Name	Time	Method
Cmax	1 week
AUClast	1 week

Secondary Outcome Measures

Name	Time	Method
AUCinf	1 week	AUCinf of DWP16001 and DWP16001 metabolites
t1/2	1 week	t1/2 of DWP16001 and DWP16001 metabolites
Tmax	1 week	Tmax of DWP16001 and DWP16001 metabolites
CL/F	1 week	CL/F of DWP16001
Vz/F	1 week	Vz/F of DWP16001
metabolic ratio	1 week	metabolic ratio of DWP16001 metabolites

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jong No Gu, South Korea