None listed
Conditions
Interventions
Intervention1: Sitagliptin100 mg Dapagliflozin 10 mg Metformin Hydrochloride 1000 mg Extended Release tablets: Name of the drug :Sitagliptin100 mg Dapagliflozin 10 mg Metformin Hydrochloride 1000
Sponsors
EAST AFRICAN INDIA OVERSEAS
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 45 years both inclusive of age 4 Body mass index in the range of 18.5 30 kg m2 both inclusive 5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician
Exclusion criteria
Exclusion criteria: 1 Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-â?? Timepoint: From Day 01 to Day 11 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2 Timepoint: From Day 01 to Day 11 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt Ltd
Outcome results
None listed