Trials / Completed
CompletedNCT06709807
Clinical Study to Evaluate the Food Effect of CKD-378 in Healthy Volunteers
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Food Effect on the Safety and the Pharmacokinetics of CKD-378 in Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Chong Kun Dang Pharmaceutical · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
Summary
This study is a randomized, open-label, single dose, crossover study to evaluate the food effect of CKD-378 in healthy volunteers
Detailed description
To 30 healthy subjects, following treatments are administered dosing in each period and wash-out period is 7 days. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CKD-378 25/1000mg | QD, PO |
Timeline
- Start date
- 2024-11-08
- Primary completion
- 2024-12-07
- Completion
- 2024-12-19
- First posted
- 2024-11-29
- Last updated
- 2025-05-21
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06709807. Inclusion in this directory is not an endorsement.