CTRI/2013/06/003762已完成未知
Comparative pharmacokinetic behavior of oral sustained release tablet formulation of metoprolol succinate with marketed extended release formulation in healthy human volunteers
Gattefosse India Pvt Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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. Study subjects must have understood and provided written informed consent after the nature of the study has been fully explained
- •2.Adult healthy volunteers of either sex in the age group of 21 to 28 years.
- •3.Weight of the healthy volunteers between 55 to 75 kg and height between 5.5 ft to 6 ft.
- •4.The subjects have not taken any drug at least 15 days prior to the study and during the study.
- •5.No previous history of hepatic, gastrointestinal and hematological diseases, known allergic reactions especially to sulfa drugs, or asthma.
- •6.Free of obvious health problems as established by medical history and screening evaluations including clinical examination
- •7.Normal hematological and biochemical parameters (Hemoglobin, RBC count, WBC count, platelet count, random blood glucose, soudium, potassium, chloride, bicarbonate, blood urea, serum creatinine, total bilirubin, direct bilirubin, SGOT, SGPT, alkaline phosphatase,) and urine parameters (specific gravity, pH, protein, glucose, ketones, blood, RBC, WBC, cast)
- •8.Negative HBsAg and HIV by ELISA
- •9.Normal ECG and chest X-ray
- •a. A female is eligible to enter and participate in study if she is of :
- •Non child bearing potential (i.e, physiologically incapable of becoming pregnant, including any female who is post menopausal): or,
- •Child bearing potential, has negative urinary pregnancy test (urine) at screening and agrees to one of the following:
- •b. Complete abstinence from intercourse for the duration of the study
- •c. Sterilization
- •d. Sterilization of male partner
- •e. Implant of levonorgestrel
- •f. Oral contraceptive (combined or progesterone only)
- •g. Any intrauterine device (IUD) with published data showing that the lowest failure rate is less than 1% per year
- •h. Any other methods with published data showing that the lowest failure rate is less than 1% per year
- •i. Barrier method only if used in combination with any of the above acceptable methods
排除标准
- •1.Consumption of any forms of tobacco, smoking, liquor drinking or drug abuse in the past 6 months
- •2.Subjects suffering from any psychiatric illness.
- •3.Subjects allergic to sulfa drugs.
- •4.Hypersensitivity to Metoprolol
- •5.Pulse rate after 10 minutes of supine position less than 50 per minute
- •6.ECG shows second / third degree heart block or sick sinus syndrome
- •7.Pregnancy confirmed by urine pregnancy test on the day of screening and on one day prior to enrollment
- •8.Nursing mothers
研究者
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