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Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects

NCT01903824 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-04-03

No results posted yet for this study

Summary

This is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of CEP-26401 (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.

Conditions

Interventions

DRUG

CEP-26401

CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.

DRUG

donepezil hydrochloride

Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated

DRUG

modafinil

modafinil 200 mg tablet, over-encapsulated

DRUG

Placebo

Placebos formulated to match each active drug

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

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 NCT01903824 on ClinicalTrials.gov