A RANDOMIZED, OPEN-LABEL, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE,MULTIPLE DOSE, CROSSOVER STUDY TO ASSESS BIOAVAILABILITY AND STEADY STATEPHARMACOKINETICS OF BACLOFEN 30 MG ER CAPSULES (GRS) OF SUNPHARMACEUTICAL INDUSTRIES LIMITED, INDIA GIVEN ONCE DAILY, UNDER FED(NORMAL MEAL) CONDITIONS, FOR 8 CONSECUTIVE DAYS.VsBACLOFEN 10 MG IR TABLETS OF IVAX PHARMACEUTICALS, INC., MIAMI, FL 33137,GIVEN THREE TIMES A DAY AT 8 HOUR INTERVAL, WITH THE INITIAL DOSEADMINISTERED UNDER FASTING CONDITION, FOR 8 CONSECUTIVE DAYS, IN 24 SPASTICSUBJECTS RECEIVING STABLE DAILY DOSES OF BACLOFEN.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Cmax, AUC and Tmax
研究概览
简要总结
The objective to monitor safety and assess bioavailability and steady-state pharmacokinetics of once daily Baclofen 30 mg Extended-Release Capsules (GRS) administered in morning or in evening in 24 spastic subjects receiving stable daily doses of Baclofen was achieved.
The pharmacokinetic parameters and Baclofen plasma concentration-time profiles were similar for the test and reference formulations. In addition, there was no significant difference in the pharmacokinetic parameters with AM or PM dosing indicating that time of dose did not influence
pharmacokinetics of Baclofen GRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Availability of subject for the entire study period and willingness to adhere to protocol requirements.
- •Subjects with history of spasticity for 1 year or more.
- •Spastic subjects receiving stable daily doses of Baclofen 30mg for at least 1-month prior to start of study.
- •Subjects at least 18-years of age or older, subjects having weight at least 50Kg and the subject’s body mass index (BMI) must be within 18.5 to 25.0 (Kg/m2) (inclusive).
排除标准
- •Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Baclofen and/or any related compounds etc.
- •Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease that interferes with study procedures.
- •Subject having history of seizure.
- •Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
结局指标
主要结局
Cmax, AUC and Tmax
时间窗: PK analysis: | pre-dose, and dosing on Day 6 (Dose 6), Day 7 (Dose 7) and Day 8 (Dose 8). On Day 8, the post-dose blood samples were collected at | 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 20.0, and 24.0 hr .
次要结局
- Vital signs (seated BP and pulse rate) and safety(after check-in, pre-dose and at 2.0,)