A Comparitive Bioavailability Study of Metformin Hydrochloride Liquid 500mg/ 5 mL Under Fasting Conditions and After Low and High Fat Meal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00778349
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Information provided by:
Ranbaxy Inc.

Brief Summary:
To assess the food effect on pharmacokinetic profile of metformin liquid 100 mg/mL of Ranbaxy Laboratories in healthy, adult, human subjecis following a dose administration of 10 mL (1000 mg) under fasting conditions, after a Iow fat meal and after a high fat meal

Condition or disease Intervention/treatment Phase
Healthy Drug: Metformin solution 100 mg/mL Not Applicable

Detailed Description:
This study was an open label, randomized, three-treatment, three-period, six-sequence, single-dose, crossover pharmacokinetic study planned on 36 healthy, adult, human subjects under fasting conditions. However 34 subjects were enrolled and 33 subjects completed all the periods of the study. All periods were separated by a washout of seven days As per protocol (Appendix 1), enough healthy, adult, human subjects were to be enrolled in the study to allow the dosing of 36 subjects in the first period. 34 subjects were enrolled and 33 subjects completed all the periods of study

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Three-Treatment, Three-Period, Six-Sequence, Single-Dose, Crossover Pharmacokinetic Study on Metformin Hydrochloride Solution 100 mg/mL of Ranbaxy Laboratories Comparing the Pharmacokinetic Profile of Metformin Under Fasting Condition, After a Low Fat Meal and After a High Fat Meal in Healthy, Adult, Human Male Subjects.
Study Start Date : April 2002
Actual Primary Completion Date : May 2002
Actual Study Completion Date : July 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Metformin solution 100 mg/mL under fasting condition
Drug: Metformin solution 100 mg/mL
Experimental: 2
Metformin solution 100 mg/mL, after low fat meal
Drug: Metformin solution 100 mg/mL
Experimental: 3
Metformin solution 100 mg/mL, after high fat meal
Drug: Metformin solution 100 mg/mL

Primary Outcome Measures :
  1. Bioavailability

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Be in the age range of 18.45 years.
  2. Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
  3. Have voluntarily given written informed consent to participate in this study.
  4. Be of normal health as determined by medical history and physical
  5. Examination of the subjects performed .within 28 days prior to the commencement of the study.
  6. If female and:

Of childbearing potential, is 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~ Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  1. History of allergy to metformin and other related antidiabetic biguanide preparations.
  2. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  3. Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection.
  4. Female volunteers demonstrating a positive pregnancy screen.
  5. Female volunteers who are currently breastfeeding.
  6. Presence of values' which are clinically significantly different from normal reference ranges for hemoglobin, total white blood cells count, differential WBC count and platelet count
  7. Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids
  8. Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se- rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol
  9. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose, (positive) and protein (positive).
  10. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
  11. History of any psychiatric illness. which may impair the ability to provide written informed consent.
  12. Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  13. History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 'unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
  14. Use of any enzyme modifying drugs within 30 days prior to Day I of this study

Additional Information:
Responsible Party: Dr. Tausif monif, Ranbaxy Research Labs Identifier: NCT00778349     History of Changes
Other Study ID Numbers: 04/METFO-500/02
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

Keywords provided by Ranbaxy Inc.:
Bioavailability Metformin solution 100 mg/mL

Additional relevant MeSH terms:
Pharmaceutical Solutions
Hypoglycemic Agents
Physiological Effects of Drugs