MedTrace Logo

Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male

NCT01404598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-08-11

No results posted yet for this study

Summary

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.

Conditions

  • Pharmacokinetics

Interventions

DRUG

naproxcinod 750 bid

naproxcinod 750 bid

DRUG

naproxcinod 3000 mg od

naproxcinod 3000 mg od

DRUG

naproxen 500 mg bid

naproxen 500 mg bid

Sponsors & Collaborators

  • NicOx

    lead INDUSTRY

Principal Investigators

  • Antonio Rusca, MD FMH · Cross Research S.A. Phase I Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404598 on ClinicalTrials.gov