A Randomized, Open Label, Two-treatment, Two -Period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl Extended-release Tablets) 750 mg of Bristol-Myers Squibb Company, USA in Normal, Healthy, Adult, Human Subjects Under Fasting Condition
Overview
- Phase
- Phase 1
- Intervention
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg
- Conditions
- Fasting
- Sponsor
- IPCA Laboratories Ltd.
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Bioequivalence is based on Cmax and AUC parameters.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fasting condition.
Detailed Description
Objective of the study is to compare and evaluate the single-dose oral bioavailability of Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India and GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb Company, USA in normal, healthy, adult, human subjects under fasting condition. Total duration of the study was of 17 days from the day of admission of first period till the end of second period. Upon entering into the study, subjects were housed in clinical facility of Veeda Clinical Research Pvt. Ltd. to ensure 10 hours overnight fasting before dosing and continued to be housed in the facility till 36.00 hours post-dose blood sample collection in each of the two periods. A gap of 14 days was kept as wash out between each consecutive dosing period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects aged between 18 and 45 years (including both).
- •Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) (including both) with minimum of 50 kg weight.
- •Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- •Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •Subjects having clinically acceptable chest X-Ray (PA view).
- •Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •Subjects having negative alcohol breathe test.
- •Subjects willing to adhere to protocol requirements and to provide written informed consent.
- •Subjects having negative Beta-hCG Pregnancy test (only for female subjects).
- •For Female Subjects:
Exclusion Criteria
- •Hypersensitivity to Metformin or to any excipients or related class of drugs.
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting
- •History or Presence of significant alcoholism or drug abuse.
- •History or presence of significant asthma, urticaria or other allergic reactions.
- •History or presence of significant gastric and/or duodenal ulceration.
- •History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •History or presence of cancer.
- •History or presence of significant easy bruising or bleeding.
- •History or presence of significant recent trauma.
Arms & Interventions
GLUCOPHAGE®XR
GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb Company, USA
Intervention: Metformin Hydrochloride Extended-Release Tablets USP 750 mg
GLUCOPHAGE®XR
GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb Company, USA
Intervention: GLUCOPHAGE®XR
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India
Intervention: Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India
Intervention: GLUCOPHAGE®XR
Outcomes
Primary Outcomes
Bioequivalence is based on Cmax and AUC parameters.
Time Frame: 1 Months
Pre-dose \& at 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00, 24.00, 30.00 and 36.00 hours post-dose.