IRCT20130313012810N31已完成Unknown
Comparative bioequivalence study of the Tizanidine Hydrochloride 4 mg tablet manufactured by Amin Pharmaceutical Company
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 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
- 年龄范围
- 18 years 至 50 years（—）
- 性别
- All
入选标准
- •The weight range of participating candidates should be between 60-100 kg.
- •Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (?-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose.
- •Volunteers who have agreed to an informed consent form.
- •All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw.
排除标准
- •History of allergic or adverse reaction to Tizanidine HCl or any similar product.
- •Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg.
- •Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s).
研究者
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