NCT01155921已完成1 期
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TABTM)1 mg Risperidone Orally Disintegrating Tablets in Healthy Adult Male Volunteers Under Fasting 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
- 36
- 主要终点
- Bioavailability based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study was to assess the single-dose relative bioavailability study of 1 mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fasting conditions.
详细描述
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr Reddy's Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TAB) 1 mg Risperidone Orally Disintegrating Tablets in Healthy Adult Male Volunteers under Fasting 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects were included in the study only if they met all of the following criteria:
- •Healthy non-smoking (for at least 3 months) adult male volunteers, 18-45 years of age;
- •Weighing at least 60 kg for males and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
- •Medically healthy subjects with clinically normal laboratory profiles and ECGs;
- •Voluntarily consent to participate in the study.
排除标准
- •Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, or psychiatric disease.
- •In addition, history or presence of:
- •alcoholism or drug abuse within the past year;
- •hypersensitivity or idiosyncratic reaction to risperidone or benzodiazepines or other antipsychotic drugs;
- •seizures;
- •glaucoma or hypermetropia.
- •Positive results on Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Virus (HCV) Tests.
- •Subjects whose sitting blood pressure is less than 110/60 mm Hg at screening or 100/55 mm Hg before dosing.
- •Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing. Subjects whose PR interval is ≥ 190 msec at screening and prior to dosing.
- •Subjects whose aTe interval is > 450 msec at screening and prior to dosing.
- •Subjects with a body temperature ≥38°C before dosing.
- •Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
- •Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- •Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- •Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days, or 1500 mL of blood in 180 days, 2500 mL of blood in 1 year.
- •Subjects who have participated in another clinical trial within 28 days prior to the first dose.
研究组 & 干预措施
Risperdal M-TAB
Active Comparator
(Risperdal M-TAB) 1 mg risperidone orally disintegrating tablets Janssen Pharmaceutica Products
干预措施: Risperidone Orally Disintegrating Tablets (Drug)
Risperidone Orally Disintegrating
Experimental
Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
干预措施: Risperidone Orally Disintegrating Tablets (Drug)
结局指标
主要结局
Bioavailability based on Cmax and AUC parameters
时间窗: 1 Month
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fed ConditionsHealthyNCT01155934Dr. Reddy's Laboratories Limited36
已完成
1 期
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) ConditionsHealthyNCT01155908Dr. Reddy's Laboratories Limited48
已完成
1 期
Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting ConditionsHealthyNCT01155895Dr. Reddy's Laboratories Limited54
已完成
1 期
Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting ConditionHealthyNCT01133444Dr. Reddy's Laboratories Limited24
已完成
1 期
Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed ConditionHealthyNCT01133457Dr. Reddy's Laboratories Limited24