Bioequivalence study of combination of Sitagliptin 100 mg Dapagliflozin 10 mg Metformin Hydrochloride 1000 mg tablets will be used in healthy subjects in fasting conditio
- Registration Number
- CTRI/2023/02/049979
- Lead Sponsor
- EAST AFRICAN INDIA OVERSEAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate Pharmacokinetics parameters Cmax, AUC0-t and AUC0-â?? Timepoint: From Day 01 to Day 11
- Secondary Outcome Measures
Name Time Method To evaluate Pharmacokinetics parameters Tmax , AUC_%Extrap_obs, λz and t1/2 Timepoint: From Day 01 to Day 11