A Randomized, Open-label, Single Dose, 2-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
- Conditions
- Diabetes Mellitus, Type II
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Cmax of Lobeglitazone
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.
Detailed Description
To healthy male subjects of 16, following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Group 1: CKD-395 0.5/1000mg 1T(Fasting) / CKD-395 0.5/1000mg 1T(Fed) Group 2: CKD-395 0.5/1000mg 1T(Fed) / CKD-395 0.5/1000mg 1T(Fasting) Pharmacokinetic blood samples are collected up to 48hrs. Investigate the effect of food on the pharmacokinetic characteristics of CKD-395
Investigators
Eligibility Criteria
Inclusion Criteria
- •A healthy male whose age is over 19 years old when visiting for initial screening test
- •Body mass index (BMI) between 17.5 \~ 30.5 kg/m\^2 and the body weight must be over 55kg
- •Body mass index (BMI) = weight (kg) / height (m)\^2
- •A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
- •Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
- •The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
- •The participants must have an ability and willingness to participate throughout the entire trials
Exclusion Criteria
- •A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nervous, or allergic (except subclinical seasonal allergies that is not treated at injection) disease.
- •Who had a history of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
- •Who had following results after examination
- •a. ALT or AST \> twice higher than normal value
- •Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (12%) (125 mL) = 12 g)
- •Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial
- •Whose blood pressure \> 140 mmHg (systolic blood pressure) or \> 90 mmHg (diastolic pressure)
- •Who had a medical history of alcohol and drug abuses.
- •Who had taken a drug that has a control of metabolic rate (activation or inhibition) in 30 days before the first taking of clinical testing drug
- •Who smokes more than 20 cigarettes per day
Arms & Interventions
Group 1
\<Group 1\> Period 1: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (Fasting condition) 7 days for wash out Period 2: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (High fat meal fed condition)
Intervention: CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
Group 2
\<Group 2\> Period 1: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (High fat meal fed condition) 7 days for wash out Period 2: administered CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T to oral (Fasting condition)
Intervention: CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T
Outcomes
Primary Outcomes
Cmax of Lobeglitazone
Time Frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Cmax of Metformin
Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
AUClast of Lobeglitazone
Time Frame: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUClast of Metformin
Time Frame: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Secondary Outcomes
- AUCinf of Lobeglitazone(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- AUCinf of Metformin(0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- Tmax of Lobeglitazone(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- t1/2 of Lobeglitazone(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- CL/F of Lobeglitazone(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- Vd/F of Lobeglitazone(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- Tmax of Metformin(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- t1/2 of Metformin(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- CL/F of Metformin(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- Vd/F of Metformin(0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)