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Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers

NCT01074710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2010-07-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK) profile of C13-URA in healthy volunteers

Conditions

Interventions

DRUG

[2-13C] uracil

po, in the form of semi-solid meal, granules, once a period

DRUG

[2-13C] uracil, placebo

po, in the form of semi-solid meal, granules, once a period

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Stephen D Flach, MD, PhD, CPI · Covance Clinical Pharmacology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01074710 on ClinicalTrials.gov