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Study of baclofen in subjects with spasticity

A RANDOMIZED, OPEN-LABEL, TWO-TREATMENT, TWO-PERIOD, TWO-SEQUENCE, MULTIPLE DOSE, CROSSOVER STUDY TO ASSESS BIOAVAILABILITY AND STEADY STATE PHARMACOKINETICS OF BACLOFEN 30 MG ER CAPSULES (GRS) OF SUN PHARMACEUTICAL INDUSTRIES LIMITED, INDIA GIVEN ONCE DAILY, UNDER FED (NORMAL MEAL) CONDITIONS, FOR 8 CONSECUTIVE DAYS. Vs BACLOFEN 10 MG IR TABLETS OF IVAX PHARMACEUTICALS, INC., MIAMI, FL 33137, GIVEN THREE TIMES A DAY AT 8 HOUR INTERVAL, WITH THE INITIAL DOSE ADMINISTERED UNDER FASTING CONDITION, FOR 8 CONSECUTIVE DAYS, IN 24 SPASTIC SUBJECTS RECEIVING STABLE DAILY DOSES OF BACLOFEN.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013139
Enrollment
24
Registered
2018-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M628- Other specified disorders of muscle Health Condition 2: null- Subjects with spasticity

Interventions

Intervention1: BACLOFEN ER CAPSULES (GRS): 30 MG once daily for 8 days Control Intervention1: BACLOFEN IR TABLETS: 10 MG Thrice daily for 8 days

Sponsors

Sun Pharmaceuticals Industries Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 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).

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Cmax, AUC and TmaxTimepoint: 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 .—

Secondary

MeasureTime frame
Vital signs (seated BP and pulse rate) and safetyTimepoint: after check-in, pre-dose and at 2.0, 4.0, 8.0, and 12.0 hours (± 30 minutes) post dose on Day 8 and at checkout (except for evening dose 4.0 and 8.0 hours (±30minutes) post dose for which blood pressure, pulse rate will be recorded in the supine position).—

Countries

India

Contacts

Public ContactDr Mudgal Kothekar

Sun Pharma Advanced Research Company Limited

clinical.trials@sparcmail.com02266455645

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026