An Open Label, Randomized, Single Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- CKD-371
- Conditions
- Type II Diabetes Mellitus
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Cmax of CKD-371, D745+D759
- Status
- Completed
- Last Updated
- 3 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 32 subjects, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D745, D759 / Test drug: CKD-371 Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults volunteers aged between 19 and 45 years old at the time of screening
- •Weight ≥50kg, with calculated body mass index (BMI) of 18.0 to 29.9 kg/m2 at the time of screening
- •Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial
Exclusion Criteria
- •Those with clinically significant diseases or history in cardiovascular system, respiratory system, liver, kidney, hematological, gastrointestinal, endocrine system, immune system, skin system, mental/nervous system, etc
- •Those who have symptoms of acute disease within 28 days of the the first dose of the investigational product
- •Those who with a history of influencing drug absorption, distribution, metabolism, and excretion
- •Those who have a hypersensitivity reaction or a history of clinically significant hypersensitivity reaction or a history of drug abuse inculding SGLT2 inhibitor class component or DPP 4 inhibitor class or same class component drugs containing ingredients
- •Those with clinically significant active chronic disease
- •Those with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption
- •A person who has had one or more of the following results in screening tests including re-examination
- •AST, ALT \> UNL (upper normal limit) x 2.5
- •Fasting glucose \< 70 mg/dL
- •Calculated by Cockcroft Gault formula Creatinine clearance is 75mL/min or less (Cockcroft Gault GFR = (140 age) \* (Wt in kg) / (72 \* Cr))
Arms & Interventions
Sequence 1
Period 1 - A single dose of 2 tablets(D745, D759) under fasting condition. Period 2 - A single dose of 1 tablets(CKD-371) under fasting condition.
Intervention: CKD-371
Sequence 2
Period 1 - A single dose of 1 tablets(CKD-371) under fasting condition. Period 2 - A single dose of 2 tablets(D745, D759) under fasting condition.
Intervention: CKD-371
Outcomes
Primary Outcomes
Cmax of CKD-371, D745+D759
Time Frame: Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr
The maximum CKD-388/D418 concentration in blood sampling time
AUCt of CKD-371, D745+D759
Time Frame: Pre-dose(0hr), post-dose 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48hr
Area under the CKD-371, D745+D759 concentration in blood-time curve from zero to final