Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose Clinical Trial
Official title:
A Combined Single Dose Study Under Fasting Condition And Multiple Doses Study Under Normal Diabetic Meal Comparing the Bioavailability of Two Formulations of 500 mg Metformin Hydrochloride Extended Release Tablets.
| 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 single centre, single-blind, randomized, balanced, combined single dose study under fasting condition and multiple doses study under fed condition with normal diabetic-meal, two-period, two-sequence cross-over study to to compare the bioavailability of metformin hydrochloride 500 mg extended release caplet (test drug) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation).
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | January 2010 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Male and female subjects with absence of significant diseases or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening. - Age of 18 - 55 years - Preferably non-smokers or smoke less than 10 cigarettes per day - Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study. - BMI 18 - 25 kg/m2 - Vital signs (after 10 minutes rest) were within the following ranges: - SBP 100 - 120 mmHg - DBP 60 - 80 mmHg - Pulse rate 60 - 90 bpm Exclusion Criteria: - Personal/family history of allergy or hypersensitivity or contraindication to metformin hydrochloride or other biguanides and allied drug. - Pregnant or lactating women and women of childbearing potential without adequate contraception - Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illnesses - Clinically significant illness within 4 weeks prior to the administration of study medication - Presence of any clinically significant abnormal values during screening - Positive Hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV - Clinically significant haematology abnormalities - Clinically significant electrocardiogram (ECG) abnormalities - Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism or excretion of the study drug - History of drug (cocaine, amphetamines, opiates, cannabis) or alcohol abuse within 12 months prior to screening for this study - Participation in any clinical trial within the past 90 days - History of any bleeding or coagulative disorders - History or presence of asthma bronchial or related bronchospastic conditions - History of seizures, epilepsy or any kind of neurological disorders - History of difficulty with donating blood or difficulty in vein puncture of left or right arm - A donation or loss of 500 mL (or more) of blood within 3 months before this study's first dosing day - Intake of any prescription or non-prescription drugs, food supplements or herbal medicines within 14 days of this study's first dosing day - Any food allergy, intolerance, restriction or special diet that in the opinion of the Research Physician, could contraindicate the subject's participation in this study - Any reason in the opinion of the Research Physician, would prevent the subject from participating in the study |
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,
Caillé G, Lacasse Y, Raymond M, Landriault H, Perrotta M, Picirilli G, Thiffault J, Spénard J. Bioavailability of metformin in tablet form using a new high pressure liquid chromatography assay method. Biopharm Drug Dispos. 1993 Apr;14(3):257-63. — View Citation
Cheng CL, Chou CH. Determination of metformin in human plasma by high-performance liquid chromatography with spectrophotometric detection. J Chromatogr B Biomed Sci Appl. 2001 Oct 5;762(1):51-8. — View Citation
Najib N, Idkaidek N, Beshtawi M, Bader M, Admour I, Alam SM, Zaman Q, Dham R. Bioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon & Glucophage)--in healthy human volunteers. Biopharm Drug Dispos. 2002 Oct;23(7):301-6. — View Citation
Scheen AJ. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 1996 May;30(5):359-71. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Bioavailability | Relative bioavailability (primarily measured by AUC and Cmax) between metformin hydrochloride 500 mg extended release caplet (test formulation) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation) at a single dose. | 24 hours | No |
| Primary | Bioavailability | Relative bioavailability (primarily measured by AUC and Cmax) between metformin hydrochloride 500 mg extended release caplet (test formulation) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation)at multiple doses. | 5 days | No |
| Secondary | Bioavailability | Relative bioavailability (secondarily measured by tmax and t1/2) between metformin hydrochloride 500 mg extended release caplet (test formulation) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation)at a single dose. | 24 hours | No |
| Secondary | Bioavailability | Relative bioavailability (secondarily measured by tmax and t1/2) between metformin hydrochloride 500 mg extended release caplet (test formulation) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation)at multiple doses. | 5 days | No |
| Secondary | Adverse events | Adverse events occurred during the study conduct (2 months) were properly and sufficiently handled and recorded. | 2 months | Yes |