Evaluating interactions between two drugs in healthy adults
A Two-arm, Open-label, Single-sequence, Multiple Oral Dosings, Crossover Clinical Trial to Evaluate the Safety and the Pharmacokinetic Interaction of DWC202313 and DWC202314 in Healthy Adult Volunteers
This study tests how two new drugs work together in healthy adults to see if they affect each other when taken at the same time.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 19 Years to 45 Years |
| Sex | All |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06119958 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and pharmacokinetic interactions of two drugs, DWC202313 and DWC202314, in healthy adult volunteers. It employs a two-arm, open-label, single-sequence, multiple oral dosing, crossover design to assess how these drugs affect each other's absorption and metabolism. Participants will receive both drugs in a controlled setting to gather data on their interactions. The study aims to provide insights into potential drug-drug interactions that could impact treatment regimens.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19 and older.
Not a fit: Patients with galactose intolerance or Lapp lactase deficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug interactions, leading to safer medication use in patients.
How similar studies have performed: While drug-drug interaction studies are common, the specific interactions of DWC202313 and DWC202314 have not been previously tested, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * over 19 year old Exclusion Criteria: * Galactose intolerance * Lapp lactase deficiency
Where this trial is running
Seoul
- H Plus YANGJI Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Seung-Hyun Kang, MD, Ph D
- Email: juspa@newyjh.com
- Phone: 070-4665-9490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.