Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers

NCT02648854 | Completed Phase 1

• 1 other identifier: 158BE15007
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (4)

• AUClast of Lobeglitazone

  0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs

• AUClast of Metformin

  0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

• Cmax of Lobeglitazone

  0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs

• Cmax of Metformin

  0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs

Secondary Outcomes (10)

• 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

Study Arms (2)

Group 1

OTHER

\<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)

Drug: CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T

Group 2

OTHER

\<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)

Drug: CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T

Interventions

CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T DRUG

administered CKD-395 0.5/1000mg 1T to oral (fasting condition)

Also known as: CKD-395 0.5/1000mg

Group 1; Group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Who took prescribed drugs or over-the-counter drugs in 10 days before taking of very first clinical testing drug
• Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs.
• Who has a potent to increase a danger by participating in the clinical trials or who can interrupt interpreting test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
• Who has a history of an extreme sensitivity of drugs that contain Rosiglitazone or drugs that have similar effect as Rosiglitazone (Pioglitazone), or drugs that contain the ingredients of Metformin or biguanidine drugs
• Who has a serious heart failure or a congestive heart failure that must be drug-treated

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Deokjin-gu, Jeonju-si, Jeollabuk-do, 561-712, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: January 7, 2016
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

KR (1)