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Clinical trial

A PHASE IV, OPEN LABEL, RANDOMIZED, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, CROSSOVER BIOEQUIVALENCE STUDY TO COMPARE AN ORAL FORMULATION OF TRAMADOL HYDROCHLORIDE 37.5 MG/PARACETAMOL 325 MG TABLETS (TEST PRODUCT OF PFIZER) VERSUS ULTRACET(REGISTERED) (TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5 MG/325 MG OF JANSSEN CILAG FARMACÊUTICA LTDA, REFERENCE PRODUCT OF BRAZIL) IN HEALTHY ADULT RESEARCH SUBJECTS UNDER FASTING CONDITIONS

NCT03803371 is registered in ClinicalTrials.gov with Pfizer as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A PHASE IV, OPEN LABEL, RANDOMIZED, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, CROSSOVER BIOEQUIVALENCE STUDY TO COMPARE AN ORAL FORMULATION OF TRAMADOL HYDROCHLORIDE 37.5 MG/PARACETAMOL 325 MG TABLETS (TEST PRODUCT OF PFIZER) VERSUS ULTRACET(REGISTERED) (TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5 MG/325 MG OF JANSSEN CILAG FARMACÊUTICA LTDA, REFERENCE PRODUCT OF BRAZIL) IN HEALTHY ADULT RESEARCH SUBJECTS UNDER FASTING CONDITIONS
Lead sponsor
Pfizer
Phase
Phase 4
Overall status
Completed
Start date
March 26, 2019
Completion date
June 28, 2019
Enrollment
60 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy