CTRI/2022/11/046993尚未招募未知
An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Oral relative bioavailability Study of Glimepiride Oral Disintegration Strip 1 mg Distributed by Sanofi Healthcare India Private Limited, India with Amaryl (glimepiride) Tablet 1 mg Manufactured by Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, USA in Healthy, Adult, Human Male Subjects Under Fed Condition.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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.Healthy, male volunteers of age between 18 and 45 years (both inclusive).
- •2. Subject weight within normal range according to normal values for Body Mass Index 18.5 to 24.9 kg per m 2 (both inclusive) with minimum of 45 kg weight.
- •3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
- •4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
- •5. Subjects having calculated eGFR value at the time of screening >= 60 ml per min.
- •6.Subjects having clinically acceptable chest X-Ray (PA view), if taken.
- •7. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
- •8. No history of drug abuse (benzodiazepines and barbiturates) for the last one month and other illegal drugs for the last 06 months.
- •9.Subjects having negative breath alcohol or urine alcohol test.
- •10. Subjects willing to adhere to protocol requirements and to provide written informed consent.
- •11. Subjects willing to follow approved birth control methods (a double barrier method) for the duration of the study until 30 days after the last dose of the study medication as judged by the investigator(s), such as (a double barrier method) Condom with spermicide, Condom with diaphragm, or abstinence or subjects should also not donate sperm during this time.
排除标准
- •1.Hypersensitivity to Glimepiride or related class of drugs or any of its excipients or heparin.
- •2.Subjects with intolerance to lactose, fructose or galactose.
- •3.History or presence of significant cardiovascular, urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 30 days prior to dosing of period 01.
- •5. Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract, bloodâ??forming organs etc.
- •6. Presence of alcoholism or drug abuse.
- •7. History or presence of smoking (for at least 6 months prior to first drug administration).
- •8. History or presence of asthma, urticaria or other significant allergic reactions.
- •9. History or presence of significant gastric and/or duodenal ulceration.
- •10. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
- •11. History or presence of cancer or basal or squamous cell carcinoma.
- •12. Difficulty with donating blood.
- •13. Subject found positive in Covid-19 RT-PCR test.
- •14. Difficulty in swallowing solids like tablets or capsules.
- •15. Any contraindication to blood sampling
- •16. Use of any prescribed medication or OTC medication including vitamins and herbal remedies during last 30 days prior to dosing in period 01.
- •17. Major illness within past 3 months.
- •18. 18.Volunteer who have donated blood (1 unit) or participation in a drug research study within past 90 days prior to the first dose of the study drug.
- •19. Consumption of xanthine-containing products, tobacco containing products or alcohol or alcoholic products for within 48.00 hours prior to dosing in period 01.
- •20. Consumption of grapefruit or grapefruit juice containing product within 72 hours prior to dosing in period 01.
- •21. Positive screening test for any one or more: HIV, HBsAg or Hepatitis C.
- •22. History or presence of significant easy bruising or bleeding or any other disorder that may cause bleeding.
- •23. History or presence of significant recent trauma.
- •24. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
- •25. Subject who has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening. Subject who had severe course of COVID 19 (ie, hospitalization, extracorporeal membrane oxygenation [ECMO], mechanically ventilated).
- •26. Any vaccination within the last 30 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Covid-19 vaccine within 30 days before inclusion.
研究者
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