A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.5/1000 mg in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg
- Conditions
- Diabetes Mellitus, Type II
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- AUClast of Lobeglitazon and metformin
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.5/1000 mg in healthy male volunteers.
Detailed Description
To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days. Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glicophage XR Tab. 1000mg 1T Treatment B(Test Drug): CKD-395 0.5/1000mg Tab. 1T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy man older than 19 years at the time of screening.
- •BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
- •Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
- •Suitable subject who is determined by laboratory tests such as hematology tests, blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
- •Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
- •Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
Exclusion Criteria
- •Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- •Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- •Subjects who show AST or AST \> 2 times upper limit of normal range.
- •Subjects who drink Alcohol \> 210g/week within 6 months prior to the screening.
- •Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- •Subjects who show Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg at screening.
- •Subjects who have history of alcohol or drug abuse, within 1 year
- •Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- •Smoker ( ≥ 20cigarettes/day)
- •Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
Arms & Interventions
TR group
T: Test drug(CKD-395 0.5/1000mg) 1T R: Reference drug(Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg) 1T
Intervention: Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg
RT group
R: Reference drug(Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg) 1T T: Test drug(CKD-395 0.5/1000mg) 1T
Intervention: Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg
RT group
R: Reference drug(Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg) 1T T: Test drug(CKD-395 0.5/1000mg) 1T
Intervention: CKD-395 0.5/1000mg
TR group
T: Test drug(CKD-395 0.5/1000mg) 1T R: Reference drug(Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg) 1T
Intervention: CKD-395 0.5/1000mg
Outcomes
Primary Outcomes
AUClast of Lobeglitazon and metformin
Time Frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Cmax of Lobeglitazon and metformin
Time Frame: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Secondary Outcomes
- Tmax of Lobeglitazon and metformin(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- CL/F of Lobeglitazon and metformin(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- Vd/F of Lobeglitazon and metformin(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- t1/2 of Lobeglitazon and metformin(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- AUCinf of Lobeglitazon and metformin(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs / Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)