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

Daewoong Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: DWP16001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07213310

DWP16001113

Details and patient eligibility

About

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

Full 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

Enrollment: 18 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: DWP16001