NCT01065987已完成1 期
Randomized, 2-way Crossover, Bioequivalence Study of Tizanidine Hydrochloride 4mg Tablets and Zanaflex® 4mg Tablets Administered As 1 x 4mg Tablet in Healthy Adult Subjects Under Fed Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bioequivalence study of Tizanidine HCl Tablets 4 mg of Dr.Reddy's Laboratories Limited under Fed Conditions
研究概览
简要总结
The purpose of this bioequivalence study is to compare the test tizanidine Hydrochloride 4mg tablets of Dr.Reddys Laboratories Limited with reference zanaflex® 4mg tablets of Elan in healthy adult subjects under fed conditions.
详细描述
Randomized, 2-way crossover, bioequivalence study of tizanidine Hydrochloride 4mg tablets and zanaflex® 4mg tablets administered As 1 x 4mg tablet in healthy adult subjects under fed conditions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc.
- •Web site). Subjects must meet all of the following criteria in order to be included in the study:
- •Subjects will be females and/or males, smokers or non-smokers, 18 years of age and older.
- •Female subjects will be post-menopausal or surgically sterilized.
- •Post-menopausal status is defined as absence of menses for the past 12 months.
- •Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
排除标准
- •Subjects to whom any of the following applies will be excluded from the study:
- •Clinically significant abnormalities found during medical screening.
- •Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- •Clinically significant illnesses within 4 weeks of the administration of study medication.
- •History of neuromuscular disease.
- •Abnormal laboratory tests judged clinically significant.
- •ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, or diastolic blood pressure lower than 70 or over 90; or heart rate less than 60 bpm) at screening.
- •Subjects with BMI ≥ 30.
- •History of allergic reactions to tizanidine hydrochloride.
- •Any food allergies, intolerances, restrictions, or special diet which in the opinion of the medical sub investigator, contraindicates the subject's participation in this study.
- •Positive urine drug screen at screening.
- •Positive testing for hepatitis B, hepatitis C or HN at screening.
- •Positive urine pregnancy test at screening.
- •Donation of plasma (500 mL) within 7 days or donation or significant loss of whole blood (500 mL) within 56 days prior to administration of the study medication.
- •History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (l Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- •History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana, pot) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- •Subjects who have taken prescription medication within 14 days prior to administration of study medication or over-the-counter products within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- •Smoking more than 25 cigarettes per day.
- •Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- •Any reason which, in the opinion of the medical sub investigator, would prevent the subject from participating in the study.
研究组 & 干预措施
Tizanidine HCl 4 mg
Experimental
Tizanidine HCl Tablets 4 mg, Dr.Reddy's Laboratories Limited
干预措施: Tizanidine (Drug)
Zanaflex
Active Comparator
Zanaflex 4 mg Tablets
干预措施: Tizanidine (Drug)
结局指标
主要结局
Bioequivalence study of Tizanidine HCl Tablets 4 mg of Dr.Reddy's Laboratories Limited under Fed Conditions
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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