Healthy
Conditions
Brief summary
Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D097 and D337 in healthy adult volunteers
Interventions
DRUGCKD-828, D097, D337, CKD-348 T1, CKD-348 T2
Subject of sequence A takes IP in the following order: 1. Each tablet of CKD-828 and D097 and D337 be taken at once 2. CKD-348 T1 1 tablet 3. CKD-348 T2 1 tabet
DRUGCKD-348 T1, CKD-348 T2, CKD-828, D097, D337,
Subject of sequence B takes IP in the following order: 1. CKD-348 T1 1 tablet 2. CKD-348 T2 1 tablet 3. Each tablet of CKD-828 and D097 and D337 be taken at once
DRUGCKD-348 T2, CKD-348 T1, CKD-828, D097, D337
Subject of sequence C takes IP in the following order: 1. CKD-348 T2 1 tablet 2. Each tablet of CKD-828 and D097 and D337 be taken at once 3. CKD-348 T1 1 tablet
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. 19 ≤ age ≤ 45 2. Health Volunteers 3. Subject who agreeds to participate in this clinical trial voluntarily
Exclusion criteria
1\. Subject who cannot participate in a clinical trial based on the PI's judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0 hour ~ 144 hr | Maximum plasma concentration of the drug |
| AUCt | 0 hour ~ 144 hour | Area under the concentration time curve from time zero to time |
Countries
South Korea
Outcome results
None listed