Healthy
Conditions
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
Interventions
DRUGDWP16001
DWP16001 enavogliflozin (single oral dose) is administered in accordance with the study protocol.
DRUGDWC202511
Repeated oral administration of DWC202511 500 mg twice daily (BID), in accordance with the study protocol.
DRUGDWC202512
Repeated oral administration of DWC202512 once daily, in accordance with the study protocol
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax | 1 week |
| AUClast | 1 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed