CTRI/2023/12/060692尚未招募Unknown
A Randomized, Open Label, Balanced, Two Treatment, Four period, Two Sequence, Single Dose, Fully replicate crossover, Bioequivalence Study of Dapagliflozin 10mg + Telmisartan 80mg manufactured by Eris Lifesciences Ltd., India with two reference products are Reference (R1); Forxiga 10 (Dapagliflozin 10 mg) Manufactured by AstraZeneca Pharmaceuticals, USA + Reference (R2); Telma 80 (Telmisartan IP 80 mg) Manufactured by Glenmark Pharmaceutical Ltd., in healthy, adult, human subjects under fasting conditions. - NI
Eris Lifesciences Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Non-Smoker Male and non-pregnant female human subjects, age in the range of 18 – 45
- •years both inclusive.
- •2. Body Mass Index between 18.5-30.0 Kg / m2 extremes included with minimum of 50 kg
- •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,
- •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 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 for the last 06 months.
- •8. Willing to provide written informed consent to participate in the study.
排除标准
- •1. Known history of hypersensitivity to Dapagliflozin and Telmisartan 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 the gastrointestinal tract, blood–forming organs, etc.
- •5. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological or psychiatric
- •6. Participation in a clinical drug study or bioequivalence study 90 days prior to Period-I dosing of the present study.
- •7. Smokers, or those who have smoked within the last six months prior to the start of the study.
- •8. History of malignancy or other serious diseases.
- •9. Blood donation 90 days prior to Period-I dosing of the present study.
- •10. Subjects with positive HIV tests, HBsAg, or Hepatitis-C tests.
- •11. Found positive in a breath alcohol test.
- •12. Found positive in a urine test for drug abuse.
- •13. History of problem in swallowing of tablet/capsule.
- •14. Any contraindication to blood sampling.
- •15. Female subjects found positive serum (ß) Beta-hCG (Human Chorionic Gonadotropin)
- •16. Lactating women (currently breast-feeding).
- •17. 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.
- •18. Male 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.
- •20. History of hypoglycemia.
- •21. History of bladder cancer and genital mycotic infections.
研究者
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