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

NCT07213310 | Completed Phase 1

• 1 other identifier: DW_DWP16001113
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Cmax

  1 week

• AUClast

  1 week

Secondary Outcomes (6)

• AUCinf

  1 week

• t1/2

  1 week

• Tmax

  1 week

• CL/F

  1 week

• Vz/F

  1 week

Study Arms (1)

Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001

EXPERIMENTAL

Drug: DWP16001; Drug: DWC202511; Drug: DWC202512

Interventions

DWP16001 DRUG

DWP16001 enavogliflozin (single oral dose) is administered in accordance with the study protocol.

Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001

DWC202511 DRUG

Repeated oral administration of DWC202511 500 mg twice daily (BID), in accordance with the study protocol.

Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001

DWC202512 DRUG

Repeated oral administration of DWC202512 once daily, in accordance with the study protocol

Single Arm: Sequential administration of DWC202511, DWC202512, and DWP16001

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers aged 19 to 50 years at the time of screening.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jong No Gu, 03080, South Korea

Location

MeSH Terms

Interventions

Enavogliflozin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: October 8, 2025
• Study Start: November 9, 2025
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

KR (1)