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

NCT00778349 | Completed DMC

• 1 other identifier: 04/METFO-500/02
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Keywords

Bioavailability Metformin solution 100 mg/mL

Outcome Measures

Primary Outcomes (1)

• Bioavailability

Study Arms (3)

1

EXPERIMENTAL

Metformin solution 100 mg/mL under fasting condition

Drug: Metformin solution 100 mg/mL

2

EXPERIMENTAL

Metformin solution 100 mg/mL, after low fat meal

Drug: Metformin solution 100 mg/mL

3

EXPERIMENTAL

Metformin solution 100 mg/mL, after high fat meal

Drug: Metformin solution 100 mg/mL

Interventions

Metformin solution 100 mg/mL DRUG

1; 2; 3

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• History of allergy to metformin and other related antidiabetic biguanide preparations.
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breastfeeding.
• 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
• Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids
• 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
• 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).
• History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
• History of any psychiatric illness. which may impair the ability to provide written informed consent.
• Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
• 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.
• Use of any enzyme modifying drugs within 30 days prior to Day I of this study

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Related Links

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: April 1, 2002
• Primary Completion: May 1, 2002
• Study Completion: July 1, 2002
• Last Updated: October 23, 2008

Record last verified: 2008-10