CTRI/2019/05/019483已完成1 期
A Randomized,Open label, Balanced, Two Treatment, Two period, Two sequence, Single Dose,Crossover, Bioequivalence study of BetahistineDihydrochloride Orally disintegrating strip (ODS) 24 mg of Shilpa Therapeutics Pvt. Ltd (Co-developed by Abbott India Ltd.) with Vertin (Betahistine) 24 mg Tablets of Abbott India Ltd., in Normal, Healthy, Adult, Male and Female Human Subjects Under Fasting Conditions. - Betahistine ODS
Shilpa Therapeutics Pvt Ltd0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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 both inclusive.
- •2. Body Mass Index between 18.5-30 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 body temperature).
- •4. Subjects with clinically acceptable findings as determined by haemogram, biochemistry (including serum electrolytes), 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 the use of tobacco products for 48.00 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 06 months.
- •8. Nonsmokers as evident from the history obtained will be included.
排除标准
- •1. Known history of hypersensitivity to Betahistinedihydrochloride 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 IMP.
- •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. Subjects with any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism and elimination of drugs.
- •8. Subjects who in the opinion of the investigator should not participate in the study.
- •9. History of malignancy or other serious diseases.
- •10. Blood donation 90 days prior to period I dosing of the present study.
- •11. Subjects with positive HIV tests, HBsAg or Hepatitis-C tests.
- •12. Found positive in breath alcohol test in each period.
- •13. Found positive in urine test for drug abuse in each period.
- •14. History of problem in swallowing.
- •15. Any contraindication to blood sampling.
- •16. Female subjects found positive serum (β) Beta- hCG (Human Chorionic Gonadotropin) test.
- •17. Lactating women (currently breast feeding).
- •18. Female subjects not confirming to using birth control measures, from the date of screening until the completion of the study. Abstinence, barrier methods (condom, diaphragm, etc.) are acceptable.
- •19. Use of hormonal contraceptives either oral or implants.
研究者
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