A Randomized, Open-Labelled, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single-Oral Dose, Bioequivalence Study Comparing Sitagliptin and Metformin Hydrochloride (Extended Release) Tablets (100mg and 1000mg) Manufactured by Optimus Pharma Pvt Ltd., India with Janumet XR CP 100mg and 1000mg (Sitagliptin Phosphate Tablets IP 100mg and Metformin Hydrochloride SR Tablets IP 1000 mg Combi pack) Marketed by MSD Pharmaceuticals Pvt Ltd., Mumbai, India in Healthy Adult Human Subjects Under Fasting Conditions.

Optimus Pharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•Volunteers meeting all the following inclusion criteria will be considered for enrolment in the
•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.

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