CTRI/2022/08/044839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 Fasting 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.Subjects weight within normal range according to normal values for Body Mass Index 18.5 to 24.9 kg/m2 (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 ââ?°Â¥ 60 ml/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, bloodââ?¬â??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.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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