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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dalim BioTech Co., Ltd.
• Treatments: Metformin; Repaglinide

Criteria

Inclusion Criteria:

1. Healthy male volunteers ages between 20 and 55 years at screening

2. Subject with Body Mass Index(BMI) with the range of 17.5 to 30.5kg/m2 and body weight over 45kg

3. Signed informed consent with the date of signature

4. With ability to comply with all the scheduled visits, treatment plans; laboratory tests and other processes.

Exclusion Criteria:

1. 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.

2. Any conditions that are likely to affect drug absorption. ex) gastrectomy

3. Positive on urine drug tests

4. 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

5. Participation in any other clinical studies within 2months prior to scheduled study drug administration

6. With Blood pressure of ≥ 160 mmHg(Systolic blood pressure) or ≥ 90 mmHg(Diastolic blood pressure) in sitting position at screening time.

7. History of any serious substance or alcohol abuse within one year prior to screening

8. Use of any drugs known to significantly induce or inhibit drug metabolizing enzyme within 30days prior to scheduled study drug administration

9. Cigarette smoking of over 20 sticks per day.

10. 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

11. Donation of whole blood within 2months or any blood products within 1month, prior to scheduled study drug administration

12. Disability to comply with the guidelines written on the protocol

13. 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

14. Hypersensitivity to chief component or excipient of Repaglinide

15. History of hypersensitivity to Metformin or Biguanide class of drugs

16. With renal failure or renal inadequacy caused by cardiovascular shock, acute myocardial infarction and sepsis

17. With Congestive heart failure and undergoing drug treatment.

18. Patients undergoing radioactive iodine uptake tests, such as intravenous urography, intravenous cholangiography, angiography, computed tomography using radioactive iodine

19. Patients with type 1 diabetes, acute or chronic metabolic acidosis including diabetic ketoacidosis associated with or without coma

20. With serious infection or trauma

21. Malnutrition, starvation; weakness; pituitary insufficiency or adrenal insufficiency

22. Patients with hepatic failure, pulmonary infarction, serious pulmonary dysfunction, or other conditions associated with hypoxemia, alcohol abuser, or dehydration, diarrhea; vomiting and gastro-intestinal disease

23. Proven to be unsuitable to participate in this clinical study by an investigator