Pharmacokinetics Clinical Trial
Official title:
A Phase 1 Study to Assess the Pharmacokinetics of Nitrates and Gamma-Hydroxybutyric Acid (GHB) After Oral Administration of Therapeutic and Supratherapeutic Doses of Naproxcinod in Healthy Male Subjects
This study will be performed in 2 parts conducted in parallel:
Part 1 (conducted on 16 healthy subjects): Administration of naproxcinod 750 mg or naproxen
500 mg twice a day (bid) during 7 days The main aim of this study part will be to assess the
pharmacokinetic profile (i.e. the absorption, the distribution, the metabolism and the
elimination of the drug after its administration) of nitrates (metabolite of naproxcinod)
present in plasma, saliva and urine after oral administration of naproxcinod 750 mg bid for
7 days or naproxen 500 mg bid for 7 days as a reference.
Part 2 (conducted on 8 healthy subjects): Administration of a single dose of naproxcinod
3000 mg. The main aim of this study part will be to assess the pharmacokinetic profile (i.e.
the absorption, the distribution, the metabolism and the elimination of the drug after its
administration) of Gamma-Hydroxybutyric Acid (GHB), a compound resulting from the
transformation of the naproxcinod, after oral administration of a single supratherapeutic
dose of 3000 mg.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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