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A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers

A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500 mg in Healthy Male Volunteers

NCT02685774•Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/500 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 + Glucophage XR Tab. 500mg 2T Treatment B(Test Drug): CKD-395 0.25/750mg Tab. 2T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.

Eligibility

Age

19 - No limit years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. A healthy male whose age is over 19 years old when visiting for initial screening test
•2. 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
•3. A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
•4. 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.
•5. 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.
•6. The participants must have an ability and willingness to participate throughout the entire trials

Exclusion Criteria

•1. 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.
•2. 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)
•3. Who had following results after examination
•a. ALT or AST \> twice higher than normal value
•4. 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)
•5. Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial
•6. Whose blood pressure \> 140 mmHg (systolic blood pressure) or \> 90 mmHg (diastolic pressure)
•7. Who had a medical history of alcohol and drug abuses.
•8. 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
•9. Who smokes more than 20 cigarettes per day
+19 more criteria

Locations (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Key Dates

Start Date

February 1, 2016

Primary Completion Date

March 1, 2016

Completion Date

April 1, 2016

Last Updated

August 9, 2017

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type II

Interventions

Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg

DRUG

CKD-395 0.25/500mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers

Inclusion Criteria

Exclusion Criteria

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