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Double-blind, Placebo Controlled, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 After Single Oral Administrations Ranging From 0.5 mg to 100 mg in Healthy Male Subjects (Part 1) Followed by the Assessment of the Effect of 3 Single Different BP1.5375 Oral Doses on Polysomnography in Comparison to 50 mg Diphenhydramine and Placebo in Healthy Male Subjects (Part 2).

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Trial Profile

Double-blind, Placebo Controlled, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 After Single Oral Administrations Ranging From 0.5 mg to 100 mg in Healthy Male Subjects (Part 1) Followed by the Assessment of the Effect of 3 Single Different BP1.5375 Oral Doses on Polysomnography in Comparison to 50 mg Diphenhydramine and Placebo in Healthy Male Subjects (Part 2).

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 23 Jan 2015

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At a glance

  • Drugs Immethridine (Primary) ; Diphenhydramine
  • Indications Unspecified
  • Focus Adverse reactions; First in man; Pharmacodynamics; Proof of concept
  • Sponsors Bioprojet

    • Most Recent Events

    • 20 Jan 2015 Status changed from not yet recruiting to discontinued as reported by ClinicalTrials.gov record.
    • 26 Oct 2013 New trial record

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