Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects

Torrent Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944177

40483

Details and patient eligibility

About

• Objective:

  • A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects.

• Study Design:

  • Randomized,single-dose,2-way crossover.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is at least 18 years old.

• Subject had no clinically significant abnormal lab values at the screening evaluation.

• Subject's drugs of abuse, Hepatitis B, Hepatitis C, and HIV screenings were negative or non-relative.

• Acceptable screening of ECG.

• Female subject's pregnancy test at screening is negative.

• Subject had no evidence of underlying disease at the pre-entry physical examination.

• Subject has given written consent to participate.

• Female subject has not received any injectable or implantable contraceptive for a period of six months preceding this study.

• Agreed to undergo at least a 14-day pre-dose washout.

• Beginning two weeks prior to dosing and throughout the study, female subject of childbearing potential agrees to utilize one of the following methods of contraception:

  1. Condom and topical spermicide
  2. Condom and diaphragm
  3. Intra-uterine device (I.U.D)
  4. Complete abstinence.

• Agree to abstain from consuming caffeine or alcohol for at least 48 hours. prior to study and throughout the blood collection periods.

Exclusion criteria

• History of treatment for alcoholism, substance abuse, or drug abuse with in the past 24 months.
• History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
• History of GRD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
• History of treatment for asthma, hypoxemia, dehydration, sepsis, metabolic acidosis and congestive heart failure.
• Subject is pregnant or lactating.
• History of drug hyper sensitivity.
• Subject was treated with any investigational drug during the four weeks prior to initial dosing for the study.
• Subject smokes more then 15 cigarettes per day or uses tobacco products or currently uses nicotine products.