Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.

Inclusion criteria

• Volunteers must meet all of the following criteria in order to be included in the study:

• Sex: male.
• Age: 18 - 45 years.
• Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
• Healthy and willing to participate in the study.
• Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
• Non-smokers or smoker who smokes less than 10 cigarettes a day.

Exclusion criteria

• The volunteers will be excluded from the study based on the following criteria:

• Clinically relevant abnormalities in the results of the laboratory screening evaluation.
• Clinically significant abnormal ECG or Chest X-ray.
• Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
• Pulse rate less than 50/minute or more than 100/minute.
• Oral temperature less than 95°F or more than 98.6°F.
• Respiratory rate less than 12/minute or more than 20/minute
• Addiction to alcohol or history of any drug abuse within the past 2 years.
• Recent History of kidney or liver dysfunction.
• History of allergy to the test drug or any drug chemically similar to the drug under investigation.
• Administration/ Intake of prescription or OTC medication for two weeks before the study.
• Patients suffering from any chronic illness such as arthritis, asthma etc.
• HIV, HCV, HBsAg positive volunteers.
• Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive volunteers based on urine test.
• Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
• Administration of any investigational products in the period 0 to 3 months before entry to the study.
• Intake of barbiturates or any enzyme-inducing drug in last three months.
• History of significant blood loss due to any reason, including blood donation in the past 12 weeks. The total blood loss in last 3 months including for this study will not exceed 350ml.
• Existence of any surgical or medical condition, which, in the judgement of the Chief Investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
• Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.