Bioequivalence Study of Sitagliptin and Metformin Hydrochloride Extended Release Tablets in a fasting conditio
- Registration Number
- CTRI/2022/04/041638
- Lead Sponsor
- Optimus Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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).
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: NI
- Secondary Outcome Measures
Name Time Method To monitor the adverse events and to ensure the safety and tolerability of single dose of investigational products (IPs).Timepoint: NI