An Open-label, Randomized, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax of CKD-501, D759, D150, CKD-393
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects
Detailed Description
To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab. Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male volunteers, aged between ≥ 19 and ≤ 55 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
- •Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
- •Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.
Exclusion Criteria
- •History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic 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
Group 1
1. Period 1: Treatment A 2. Period 2: Treatment B 3. Period 3: Treatment C
Intervention: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
Group 1
1. Period 1: Treatment A 2. Period 2: Treatment B 3. Period 3: Treatment C
Intervention: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
Group 1
1. Period 1: Treatment A 2. Period 2: Treatment B 3. Period 3: Treatment C
Intervention: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
Group 2
1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B
Intervention: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
Group 2
1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B
Intervention: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
Group 2
1. Period 1: Treatment A 2. Period 2: Treatment C 3. Period 3: Treatment B
Intervention: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
Group 3
1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C
Intervention: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
Group 3
1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C
Intervention: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
Group 3
1. Period 1: Treatment B 2. Period 2: Treatment A 3. Period 3: Treatment C
Intervention: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
Group 4
1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A
Intervention: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
Group 4
1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A
Intervention: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
Group 4
1. Period 1: Treatment B 2. Period 2: Treatment C 3. Period 3: Treatment A
Intervention: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
Group 5
1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B
Intervention: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
Group 5
1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B
Intervention: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
Group 5
1. Period 1: Treatment C 2. Period 2: Treatment A 3. Period 3: Treatment B
Intervention: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
Group 6
1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A
Intervention: CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T
Group 6
1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A
Intervention: CKD-393 0.5/100/1000mg formulation 1 Tab. 1T
Group 6
1. Period 1: Treatment C 2. Period 2: Treatment B 3. Period 3: Treatment A
Intervention: CKD-393 0.5/100/1000mg formulation 2 Tab. 1T
Outcomes
Primary Outcomes
Cmax of CKD-501, D759, D150, CKD-393
Time Frame: Time Frame: 0 hour ~ 48 hours
The maximum CKD-501/D759/D150/CKD-393 concentration in blood sampling time t
AUCt of CKD-501, D759, D150, CKD-393
Time Frame: Time Frame: 0 hour ~ 48 hours
Area under the CKD-501/D759/D150/CKD-393 concentration in blood-time curve from zero to final