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Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayed-release Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (Test Product: Product of Tecnandina, S.A. TENSA; Reference Product: Diclegis (Registered Trademark) Product of Duchesnay Inc.) After a Single Administration of Two Tablets to Healthy Women Under Fasting Conditions

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Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayed-release Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (Test Product: Product of Tecnandina, S.A. TENSA; Reference Product: Diclegis (Registered Trademark) Product of Duchesnay Inc.) After a Single Administration of Two Tablets to Healthy Women Under Fasting Conditions

Status: Withdrawn prior to enrolment
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Doxylamine/pyridoxine (Primary)
  • Indications Unspecified
  • Focus Pharmacokinetics
  • Sponsors Grunenthal

    • Most Recent Events

    • 18 Jun 2019 Planned initiation date changed from 1 May 2019 to 1 Jun 2019.
    • 18 Jun 2019 Status changed from not yet recruiting to withdrawn prior to enrolment.
    • 24 Apr 2019 New trial record

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