CTRI/2018/04/012998已完成未知
A Randomized, Balanced, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Cetapin-XR (as Metformin Hydrochloride) Sustained Release Tablets, 500 mg of Sanofi India Ltd. with GLUCOPHAGE® XR (Metformin Hydrochloride) Extended-Release Tablets, 500 mg of Bristol-Myers Squibb Company Princeton, NJ 08543 USA in Normal, Healthy, Adult Male and Female Subjects under fed and Fasting Conditions - Cetapin XR
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Male and non pregnant female human subjects, age in the range of 18 â?? 45 years.
- •2. Body Mass Index between 18.5-24.9 Kg / m2 extremes included. 3.Subjects with normal findings as determined by baseline history, physical
- •examination and vital sign examination (blood pressure, pulse rate, respiration
- •rate and axillary temperature).
- •4. Subjects with clinically acceptable findings as determined by haemogram,
- •biochemistry, urinalysis, 12 lead ECG and chest X-ray (if done).
- •5. Willingness to follow the protocol requirements especially abstaining from
- •xanthine containing food or beverages (chocolates, tea, coffee or cola drinks) or
- •grapefruit juice, any alcoholic products, the use of cigarettes and tobacco
- •products for 48 hours prior to dosing until after the last blood sample collection in
- •each study period and adherence to food, fluid and posture restrictions.
- •6. No history of significant alcoholism.
- •7. No history of drug abuse (benzodiazepines and barbiturates) for the last one
- •month and other illegal drugs (Appendix B) for the last 6 months.
- •8. Non-smokers, ex-smokers and moderate smokers will be included. â??Moderate
- •smokers are defined as someone smoking 10 cigarettes or less per day,
- •ex-smokers are someone who completely stopped smoking for at least 3 months.â??
排除标准
- •1. Known history of hypersensitivity to Metformin hydrochloride or related drugs.
- •2. Requiring medication for any ailment having enzyme-modifying activity in the
- •previous 28 days, prior to dosing day.
- •3. Subjects who have taken prescription medications or over-the-counter products
- •(including vitamins and minerals) within 14 days prior to administration of
- •Investigational Product.
- •4. Any medical or surgical conditions, which might significantly interfere with the
- •functioning of gastrointestinal tract, bloodâ??forming organs etc.
- •5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,
- •metabolic, haematological, gastrointestinal, endocrine, immunological or
- •psychiatric diseases.
- •6. Participation in a clinical drug study or bioequivalence study 90 days prior to
- •period I dosing of the present study.
- •7. History of malignancy or other serious diseases.
- •8. Blood donation 90 days prior to period I dosing of the present study.
- •9. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
- •10. Found positive in breath alcohol test.
- •11. Found positive in urine test for drug abuse.
- •12. History of problem in swallowing.
- •13. Any contraindication to blood sampling.
- •14. Found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
- •15. Lactating women (currently breast feeding).
- •16. Female subjects not confirming to using birth control measures, from the date of
- •screening until the completion of the study. (Note: Abstinence, barrier methods
- •e.g. condom, diaphragm, etc. are acceptable.)
- •17. Use of hormonal contraceptives either oral or implants.
研究者
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