Bioequivalence Study of 4 mg Glimepiride Tablet

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dexa Medica Group
• Treatments: Glimepiride

Criteria

Inclusion Criteria:

1. Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

2. Age of 18 - 55 years

3. Preferably non-smokers or moderate smokers (less than 10 cigarettes per day)

4. Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study

5. BMI 18 - 25 kg/m2

6. Vital signs (after 10 minutes rest) must be within the following ranges:

• SBP 100 - 120 mmHg

• DBP 60 - 80 mmHg

• Pulse rate 60 - 90 bpm

Exclusion Criteria:

1. Personal/family history of allergy or hypersensitivity or contraindication to glimepiride or allied drugs

2. Pregnant or lactating women

3. Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness

4. Presence of any clinically significant abnormal values during screening

5. Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV

6. Clinically significant haematology abnormalities

7. Clinically significant electrocardiogram (ECG) abnormalities

8. Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug

9. Past history of anaphylaxis or angioedema

10. History of drug or alcohol abuse within 12 months prior to screening

11. Participation in any clinical trial within the past 90 days

12. History of any bleeding or coagulative disorders

13. History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm

14. A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day

15. Intake of any prescription, non-prescription drug, food supplements or herbal medicines within 14 days of this study's first dosing day