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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778349 |
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 | Intervention |
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Healthy |
Drug: Metformin solution 100 mg/mL |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-availability Study |
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. |
Enrollment: | 34 |
Study Start Date: | April 2002 |
Study Completion Date: | July 2002 |
Primary Completion Date: | May 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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
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Drug: Metformin solution 100 mg/mL |
3: Experimental
Metformin solution 100 mg/mL, after high fat meal
|
Drug: Metformin solution 100 mg/mL |
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
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif monif ) |
Study ID Numbers: | 04/METFO-500/02 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778349 |
Health Authority: | India: Drugs Controller General of India |
Bioavailability Metformin solution 100 mg/mL |
Metformin Healthy |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |