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Completed

NCT Number: NCT07213310

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

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

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Key information

Conditions

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, Jong No Gu, 03080, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DWP16001

Drug

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

DWC202511

Drug

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

DWC202512

Drug

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

Primary outcomes

  1. Cmax

    Time frame: 1 week

  2. AUClast

    Time frame: 1 week

Secondary outcomes

  1. AUCinf

    Time frame: 1 week

    AUCinf of DWP16001 and DWP16001 metabolites

  2. t1/2

    Time frame: 1 week

    t1/2 of DWP16001 and DWP16001 metabolites

  3. Tmax

    Time frame: 1 week

    Tmax of DWP16001 and DWP16001 metabolites

  4. CL/F

    Time frame: 1 week

    CL/F of DWP16001

  5. Vz/F

    Time frame: 1 week

    Vz/F of DWP16001

  6. metabolic ratio

    Time frame: 1 week

    metabolic ratio of DWP16001 metabolites

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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