None listed
Conditions
Interventions
Intervention1: Metformin Hydrochloride 1000 mg tablet: Single oral dose of 1000 mg tablet one time only
Control Intervention1: Glucophage 1000 mg tablet: Single oral dose of 1000 mg tablet one time on
Sponsors
Next wave India
Eligibility
Inclusion criteria
Inclusion criteria: 1 Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 (g/dL) for men and 12 to 16 g/dL for female 6 Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
Exclusion criteria
Exclusion criteria: 1 Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening. 2 Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 3 Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs. 4 History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 5 History of severe infection or major surgery in the past 6 months. 6 History of Minor surgery or fracture within the past 3 months 7 Any major illness or hospitalized within 90 days prior to the first dosing. 8 Any other clinical condition like diarrhea or vomiting within three days prior to dosing. 9 Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening. 10 Use of any depot injection or an implant of any drug within three months prior to dosing and throughout the study periods. 11 History of difficulty in accessibility of veins in arms. 12 Evidence of an uncooperative attitude.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare rate and extend of orally administered molecule to prove bioequivalence on Metformin Hydrochloride 1000 mg tablet of Next wave with Glucophage 1000 mg tablet (Metformin Hydrochloride 1000 mg) of M/S Merck Serono in healthy adult human subjects under fasting conditions.Timepoint: Day 1 to day 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety of the study subjects after administration of Metformin Hydrochloride 1000 mg tablets in healthy adult human subjects under fasting conditionsTimepoint: Day 1 to day 12 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed