A Pharmacokinetic Study to Compare Co-administration of Repaglinide and Metformin HCl to Administration of Combination Preparation of Those Two Components

NCT01780051 | Completed Phase 1

• 1 other identifier: RM0818-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase-1, single center, open-label, randomized, single-dose, 2-way crossover study. The objective of the study is to compare the pharmacokinetic properties after co-administration of Repaglinide 2mg and Metformin hydrochloride 500mg with administration of combination preparation of Repaglinide 2mg and Metformin hydrochloride 500mg in 50 healthy male volunteers.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• AUCt and Cmax of repaglinide and metformin

  Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration.

Secondary Outcomes (1)

• AUC∞, Tmax, t1/2, CL/F and Vd/F of repaglinide and metformin

  Before study drug administration(0h) and after 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h of study drug administration.

Study Arms (2)

Sequence A

EXPERIMENTAL

Drug: Repaglinide/Metformin combination, Repaglinide, Metformin

Sequence B

EXPERIMENTAL

Drug: Repaglinide/Metformin combination, Repaglinide, Metformin

Interventions

Repaglinide/Metformin combination, Repaglinide, Metformin DRUG

Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 1. Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 2.

Sequence A

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers ages between 20 and 55 years at screening
• Subject with Body Mass Index(BMI) with the range of 17.5 to 30.5kg/m2 and body weight over 45kg
• Signed informed consent with the date of signature
• With ability to comply with all the scheduled visits, treatment plans; laboratory tests and other processes.

You may not qualify if:

• Positive of blood, kidney, endocrine, lung, gastro-intestinal, cardiovascular, hepatic, psychiatric, nervous, allergy; or with past and present disease history or symptoms that are clinically significant.
• Any conditions that are likely to affect drug absorption. ex) gastrectomy
• Positive on urine drug tests
• History of drinking alcohol more than 12 ounces(360mL) of beer, 1.5 ounces(45mL) of liquor; or 21 drinks/week(1drink = 5 ounces(150mL) of wine ) 6months prior to screening
• Participation in any other clinical studies within 2months prior to scheduled study drug administration
• With Blood pressure of ≥ 160 mmHg(Systolic blood pressure) or ≥ 90 mmHg(Diastolic blood pressure) in sitting position at screening time.
• History of any serious substance or alcohol abuse within one year prior to screening
• Use of any drugs known to significantly induce or inhibit drug metabolizing enzyme within 30days prior to scheduled study drug administration
• Cigarette smoking of over 20 sticks per day.
• Use of any prescription drugs or any over the counter drugs within 10days or quintuple half life(whichever is longer) prior to scheduled study drug administration
• Donation of whole blood within 2months or any blood products within 1month, prior to scheduled study drug administration
• Disability to comply with the guidelines written on the protocol
• Severe acute/chronic medical, physical disorder or laboratory test abnormality that are likely to alter the study result and increase the risk by participating in the study and study drug administration
• Hypersensitivity to chief component or excipient of Repaglinide
• History of hypersensitivity to Metformin or Biguanide class of drugs

Sponsors & Collaborators

• Dalim BioTech Co., Ltd.: lead

Study Sites (1)

Chounbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

repaglinide; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Min-Gul Kim, doctor

  Chounbuk National University Hospital

  PRINCIPAL INVESTIGATOR

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: January 29, 2013
• First Posted: January 30, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

KR (1)