CTRI/2020/09/027660已完成1 期
A Prospective, Interventional, Open label, Phase 1, single-centre, single fasting dose study to evaluate the safety and tolerability of ATRICOV 452 capsule of 500 mg in healthy adult human subjects.
Atrimed Pharmaceutical 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
- 1 期
- 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
- Interventional
入排标准
入选标准
- •1. Normal, healthy, adult, male human subject
- •of 18-45 years of age.
- •2. Body mass index in the range of 18.50 â??
- •24.90 kg/m2.
- •3. Willing to provide written informed consent
- •for participation in the study, and an
- •ability to comprehend the nature and purpose
- •of the study.
- •4. Willing to be available for the entire study
- •period and to comply with protocol
- •requirements. Normal haemoglobin between 13.8
- •to 17.2 grams per deciliter (g/dL).
- •5. Normal health status as determined by
- •baseline medical and medication history, at
- •the time of screening and vital signs (blood
- •pressure, pulse rate, respiratory rate, and
- •axillary temperature) measurements and
- •physical examination at the time screening as
- •well as check-in for the study.
排除标准
- •1.Women of child bearing age, children
- •2.Any medical or surgical conditions, which
- •might significantly interfere with the
- •functioning of the gastrointestinal tract and
- •bloodâ??forming organs.
- •3.History of severe infection or major surgery
- •in the past 6 months.
- •4.History of Minor surgery or fracture within
- •the past 3 months.
- •5. Significant history or current evidence of
- •malignancy or chronic- infectious,
- •cardiovascular, renal, hepatic, ophthalmic,
- •pulmonary, neurological, metabolic
- •(endocrine), hematological, gastrointestinal,
- •immunological or psychiatric diseases, or
- •organ dysfunction.
- •6.Any major illness or hospitalized within 90
- •days prior to the dosing.
- •7.Any other clinical condition like diarrhea or
- •vomiting within three days prior to dosing.
- •8.Use of any depot injection or an implant of
- •any drug within three months prior to dosing
- •and throughout the study periods.
- •9.Use of any prescribed medication (including
- •herbal medicines and vitamin supplements)
- •within 30 days or within five half-lives of
- •the drug, whichever is longer prior to dosing
- •and throughout the study.
- •10.Use of any OTC products within 14 days or
- •within five half-lives of the drug, whichever
- •is longer prior to dosing and throughout the
- •11.History or presence of significant gastric
- •or duodenal ulceration.
- •12.Use of any recreational drug or history of
- •drug addiction.
研究者
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