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A MULTICENTRIC OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO PERIOD, TWO-SEQUENCE, CROSSOVER, STEADY STATE, DOSAGE STRENGTH EQUIVALENCE STUDY OF CLOZAPINE EXTENDED RELEASE CAPSULE 25 MG (LOWEST STRENGTH, 25 MG X 8 CAPSULES) ONCE DAILY (TEST DRUG, INTAS PHARMACEUTICALS LIMITED, INDIA) WITH CLOZAPINE EXTENDED RELEASE CAPSULE 200 MG (HIGHEST STRENGTH) ONCE DAILY (TEST DRUG, INTAS PHARMACEUTICALS LIMITED, INDIA) AFTER MULTIPLE DOSE ADMINISTRATION IN ADULT SCHIZOPHRENIC PATIENTS UNDER FASTING CONDITIONS.

Trial Profile

A MULTICENTRIC OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO PERIOD, TWO-SEQUENCE, CROSSOVER, STEADY STATE, DOSAGE STRENGTH EQUIVALENCE STUDY OF CLOZAPINE EXTENDED RELEASE CAPSULE 25 MG (LOWEST STRENGTH, 25 MG X 8 CAPSULES) ONCE DAILY (TEST DRUG, INTAS PHARMACEUTICALS LIMITED, INDIA) WITH CLOZAPINE EXTENDED RELEASE CAPSULE 200 MG (HIGHEST STRENGTH) ONCE DAILY (TEST DRUG, INTAS PHARMACEUTICALS LIMITED, INDIA) AFTER MULTIPLE DOSE ADMINISTRATION IN ADULT SCHIZOPHRENIC PATIENTS UNDER FASTING CONDITIONS.

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 29 Jan 2020

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At a glance

  • Drugs Clozapine (Primary)
  • Indications Schizophrenia
  • Focus Pharmacokinetics
  • Sponsors Intas Pharmaceuticals
  • Most Recent Events

    • 29 Jan 2020 New trial record

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