Chong Kun Dang Pharmaceutical
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers under Fasting Conditions
Cardiovascular Diseases
CKD-385
D744
Phase 1
A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-385 high-dose in healthy volunteers under fasting conditions
Study Type : | Interventional |
Estimated Enrollment : | 52 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-385 High-dose in Healthy Volunteers Under Fasting Conditions |
Actual Study Start Date : | June 4, 2021 |
Estimated Primary Completion Date : | July 16, 2021 |
Estimated Study Completion Date : | July 23, 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Sequence1 Period 1: Reference drug(D744) Period 2: Test drug(CKD-385) |
Drug: CKD-385 Drug: D744 |
Experimental: Sequence2 Period 1: Test drug(CKD-385) Period 2: Reference drug(D744) |
Drug: CKD-385 Drug: D744 |
Ages Eligible for Study: | 19 Years to 54 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Chonbuk National University Hospital
Jeonju, Korea, Republic of,