Glimepiride BE Study in Healthy Volunteers Under Fasting Condition Clinical Trial
Official title:
Bioequivalence Study of Two Formulations of Glimepiride Tablet in Healthy Subjects
Verified date | August 2012 |
Source | Dexa Medica Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 24 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | PT Equilab International | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Dexa Medica Group |
Indonesia,
Jovanovic D, Stojsic D, Zlatkovic M, Jovic-Stosic J, Jovanovic M. Bioequivalence assessment of the two brands of glimepiride tablets. Vojnosanit Pregl. 2006 Dec;63(12):1015-20. — View Citation
Malerczyk V, Badian M, Korn A, Lehr KH, Waldhäusl W. Dose linearity assessment of glimepiride (Amaryl) tablets in healthy volunteers. Drug Metabol Drug Interact. 1994;11(4):341-57. — View Citation
Salem II, Idrees J, Al Tamimi JI. Determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 5;799(1):103-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioavailability | Relative bioavailability (primarily measured by AUC and Cmax) between two glimepiride 4 mg tablet formulations (test and reference formulations) under fasting condition. | 24 hours | No |
Secondary | Bioavailability | Relative bioavailability (secondarily measured by tmax and t1/2) between two formulations of glimepiride 4 mg tablets (the Test and Reference formulations) | 24 hours | No |
Secondary | Adverse events | The presence of adverse events will be observed, reported and sufficiently handled during subjects' participation in the study (1 month). | 1 months | Yes |