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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.

Trial Profile

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: Completed
Phase of Trial: Phase II

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Baclofen (Primary) ; Baclofen
  • Indications Muscle spasticity
  • Focus Pharmacokinetics
  • Sponsors Sun Pharmaceutical Industries
  • Most Recent Events

    • 25 Jun 2018 New trial record
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