An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-388 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- D418 Tab.
- Conditions
- Chronic Hepatitis b
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- AUCt of CKD-388, D418
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-388 in healthy subjects
Detailed Description
To healthy subjects of fifty-six (56), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days. Reference drug: D418 Tab. / Test drug: CKD-388 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.
- •Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2
- •\* BMI = Weight(kg)/ Height(m)2
- •Individuals who agreed proper contraception during the study and did consent to not donation of sperm 1 month after the last dose of Investigational Product (IP) administration
- •Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical tail
Exclusion Criteria
- •History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
- •With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
- •Any medical history that may affect drug absorption, distribution, metabolism and excretion.
- •Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse
- •Thiazolidinedione
- •DPP-4 inhibitor
- •Metformin
- •Any clinically significant chronic medical illness.
- •Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Individuals with one of the following laboratory test results in screening
Arms & Interventions
Reference-Test
Intervention: D418 Tab.
Reference-Test
Intervention: CKD-388 Tab.
Test-Reference
Intervention: D418 Tab.
Test-Reference
Intervention: CKD-388 Tab.
Outcomes
Primary Outcomes
AUCt of CKD-388, D418
Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
Area under the CKD-388/D418 concentration in blood-time curve from zero to final
Cmax of CKD-388, D418
Time Frame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.50, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72 hours
The maximum CKD-388/D418 concentration in blood sampling time t