None listed
Conditions
Interventions
Intervention1: Metformin Hydrochloride 1000 mg XR tablet: single dose one time only one day
Control Intervention1: Glucophage 1000 mg XR tablet: single dose one time only one day
Sponsors
Labratories Leti SAV
Eligibility
Inclusion criteria
Inclusion criteria: 1.Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2.Willing to be available for the entire study period and to comply with protocol requirements. 3.Normal, healthy, adult, human subject of 18-55 years (both inclusive) of age. 4.Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive). 5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (gm/dl) for men and 12 to 16 gm/dl for female or as per the discretion of PI/CI/Physician. 6.Normal health status as determined by medical history and physical examination by the PI/CI/Physician at the time of screening and vital signs (blood pressure) 7 With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1). 8 With a normal or clinically non-significant 12-lead ECG. 9 With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies, Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV) antibodies.
Exclusion criteria
Exclusion criteria: 1.Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs. 2.History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 3.History of severe infection or major surgery in the past 6 months. 4.History of Minor surgery or fracture within the past 3 months. 5.Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction. 6.Any major illness or hospitalization within 90 days prior to check-in of first period. 7.Any other clinical condition like diarrhea or vomiting within three days prior to check-in of any period. 8.Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during four weeks before check-in of the first period and throughout the duration of the study until the post study safety sample is collected. 9.Use of any depot injection or an implant of any drug within three months prior to check-in of the first period and throughout the duration of the study until the post study safety sample is collected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of orally administered Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., with that of Glucophage 1000 mg XR tablet (Metformin Hydrochloride 1000 mg) of Merck Serono GmbH in healthy adult human subjects under fasting conditions. -Cmax, and AUC0-t and Timepoint: Day 1 to day 11 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of the study subjects after administration of Metformin Hydrochloride 1000 mg XR tablet in healthy adult human subjects under fasting conditions. Tmax, λz and t1/2Timepoint: Day 1 to day 11 during the study | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed