Clinical trial NCT01089166: Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition
Official title: To Compare the Bioavailability of Extended Release Metformin HCl Tablet(Test Formulation, Torrent Pharmaceuticals Ltd.,India) Versus Glucophage XR® Tablets ( Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers Under Fasting Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Torrent Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2010-03-18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT

Brief summary: Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition.

Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.


Eligibility criteria: Inclusion Criteria:

* Subjects must meet all of the following criteria in order to be included in the study:

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

Exclusion Criteria:

* The subjects will be excluded from the study based on the following criteria:

  1. Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  2. Clinically significant abnormal ECG or Chest X-ray.
  3. 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.
  4. Pulse rate less than 50/minute or more than 100/minute.
  5. Oral temperature less than 95°F or more than 98.6°F.
  6. Respiratory rate less than 12/minute or more than 20/minute
  7. Addiction to alcohol or history of any drug abuse within the past 2 years.
  8. Recent History of kidney or liver dysfunction.
  9. History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  10. Administration/ Intake of prescription or OTC medication for two weeks before the study.
  11. Patients suffering from any chronic illness such as arthritis, asthma etc.
  12. HIV, HCV, HBsAg positive Subjects.
  13. Opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, Cocaine positive Subjects based on urine test.
  14. Subjects suffering from any psychiatric (acute or chronic) illness requiring medications.
  15. Administration of any investigational products in the period 0 to 3 months before entry to the study.
  16. Intake of barbiturates or any enzyme-inducing drug in last three months.
  17. 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.
  18. History of any bleeding disorder.
  19. 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 Subjects.
  20. Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bhat
country: India
facility: Torrent Research Centre
state: Gujarat
Study officials:
affiliation: Torrent Pharma Ltd.
name: Jogesh mahajan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: