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.

Sun Pharmaceuticals Industries Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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
•subjectâ??s body mass index (BMI) must be within 18.5 to 25.0 (Kg/m2) (inclusive).

•- 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

发起方

Sun Pharmaceuticals Industries Ltd