None listed
Conditions
Interventions
Intervention1: Sitagliptin and Metformin
Hydrochloride (Extended
Release) Tablets (100mg and
1000mg): Sitagliptin and Metformin
Hydrochloride (Extended
Release) Tablets (100mg and
1000mg)
Manufactured
Sponsors
Optimus Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers meeting all the following inclusion criteria will be considered for enrolment in the study: 1. Healthy human subjects aged between 18 years and 45 years (both inclusive). 2. Having a Body Mass Index (BMI) between 18.50 and 24.90 kg/m2 (both inclusive). 3. All volunteers must be judged by the Principal or Co-investigator or physician as normal and have no abnormal (clinically significant) findings during screening (medical history and examination, vitals, laboratory evaluations and ECG recording) within 28 days and chest X-Ray evaluation within 06 months prior to period-I dosing of study drug. 4. Subjects willing to adhere to protocol requirements and provide written informed consent. 5. Females who are a) Childbearing potential 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 devices (IUD) or abstinence: or b) Post-menopausal for at least 1 year, or c) Surgically sterile (has undergone bilateral tubal ligation, bilateral; oophorectomy or hysterectomy).
Exclusion criteria
Exclusion criteria: Volunteers will be excluded from participation in the study, if they meet any one of the following exclusion criteria: 1. History of allergic responses to Sitagliptin and Metformin or any related products or related drugs, or any of its formulation ingredients. 2. History or evidence of using any other Anti-diabetic drugs. 3. Any disease or condition which might compromise the hematopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, genital or any other body system. 4. Participation in any clinical research study or any bioavailability/bioequivalence study within 90 days prior to first dosing of the present study. 5. Blood donation within 90 days prior to first dosing of the present study. 6. History of difficulty in donating blood. 7. History or evidence of drug dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Sitagliptin And Metformin Hydrochloride (Extended Release) Tablets (100mg and 1000mg) Manufactured by Optimus Pharma Pvt Ltd., India and Janumet XR CP 100mg/1000mg (Sitagliptin Phosphate Tablets IP 100mg and Metformin Hydrochloride SR Tablets IP 1000 Mg Combipack) Marketed by MSD Pharmaceuticals Pvt Ltd., Mumbai, India in Healthy, Adult, Human Subjects Under Fasting Condition.Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the adverse events and to ensure the safety and tolerability of single dose of investigational products (IPs).Timepoint: NIL | — |
Countries
India
Contacts
Public ContactVinayak Sargar
Admerus Biosciences Private Limited
Outcome results
None listed