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Oral Civamide Safety, Tolerability First in Human Study

NCT00802217 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-06-10

No results posted yet for this study

Summary

Safety and pharmacokinetic first-time-in-human study of orally administered civamide in healthy subjects.

Conditions

  • Healthy

Interventions

DRUG

Civamide

5 mg liquid filled softgel capsules

DRUG

Civamide

5 mg x 2 liquid softgel capsules

Sponsors & Collaborators

  • Winston Laboratories

    lead INDUSTRY

Principal Investigators

  • Scott B Phillips, M D · Winston Laboratories

  • Shwe Gyaw, M D · Parexel

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • United States

Study Locations

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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 NCT00802217 on ClinicalTrials.gov