Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fasting Condition

NCT01831661 | Completed Phase 1 DMC

• 1 other identifier: 10-VIN-183
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence is based on Cmax and AUC parameters.

  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.

  1 Months

Study Arms (2)

GLUCOPHAGE®XR

ACTIVE COMPARATOR

GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb Company, USA

Drug: Metformin Hydrochloride Extended-Release Tablets USP 750 mg; Drug: GLUCOPHAGE®XR

Metformin Hydrochloride Extended-Release Tablets USP 750 mg

EXPERIMENTAL

Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India

Drug: Metformin Hydrochloride Extended-Release Tablets USP 750 mg; Drug: GLUCOPHAGE®XR

Interventions

Metformin Hydrochloride Extended-Release Tablets USP 750 mg DRUG

Metformin Hydrochloride Extended-Release Tablets 750 mg once a day

Also known as: Test Product

GLUCOPHAGE®XR; Metformin Hydrochloride Extended-Release Tablets USP 750 mg

GLUCOPHAGE®XR DRUG

GLUCOPHAGE®XR 750 mg once a day

Also known as: Reference product

GLUCOPHAGE®XR; Metformin Hydrochloride Extended-Release Tablets USP 750 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• \) Female of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or 2) Postmenopausal for at least 1 year, or if less than 1 year, then following acceptable contraceptive measures as mentioned above 3) Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

You may not qualify if:

• 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.
• Subjects who have been on an abnormal diet (for whatever reason) during four weeks preceding the study.
• Difficulty with donating blood.
• Difficulty in swallowing solids like tablets or capsules.
• Use of any prescribed or OTC medication during last two weeks prior to dosing in period 01.
• Consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol within 48 hours prior to dosing.

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Veeda Clinical Research Pvt. Ltd.

Ahmedabad, Gujarat, 380 015, India

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Dr. Hardik Dave, M.B.B.S

  Veeda Clinical Research Pvt. Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2013
• First Posted: April 15, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

IN (1)