Clinical trial
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).
NCT01965301 is registered in ClinicalTrials.gov with Bioprojet as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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).
- Lead sponsor
- Bioprojet
- Phase
- Phase 1
- Overall status
- Terminated
- Start date
- October 31, 2014
- Completion date
- December 31, 2014
- Enrollment
- 48 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
healthy male volunteers