A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers

NCT02627027 | Completed Phase 1

• 1 other identifier: 158BE15004
• 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 compare the pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (4)

• AUClast of Lobeglitazone

  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

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

• Cmax of Lobeglitazone

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

• Cmax of Lobeglitazone Metformin

  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

  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

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

• Tmax of Lobeglitazone

  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

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

• t1/2 of Lobeglitazone

  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)

RT group

EXPERIMENTAL

R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) T: Test drug(CKD-395 0.25/750 mg 2T)

Drug: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg; Drug: CKD-395 0.25/750mg

TR group

EXPERIMENTAL

T: Test drug(CKD-395 0.25/750 mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T)

Drug: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg; Drug: CKD-395 0.25/750mg

Interventions

Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg DRUG

oral administration

Also known as: Lobeglitazone Sulfate 0.5mg, Metformin HCl 1500mg

RT group; TR group

CKD-395 0.25/750mg DRUG

oral administration

Also known as: Lobeglitazone Sulfate 0.25mg, Metformin HCl 750mg

RT group; TR group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
• Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
• Patients with hypersensitivity to lobeglitazone or any other thiazolidinediones ( Rosiglitazone, Rioglitazone) and to Metformin or any other biguanides
• Patients with severe heart failure or congestive heart failure of needing drug therapy
• Patients with liver disease

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Tablets; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals

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 8, 2015
• First Posted: December 10, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 6, 2016

Record last verified: 2016-01

Locations

KR (1)