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Multi-Dose Safety and Pharmacokinetic Study of S-Equol in Healthy Volunteers

NCT00998920 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2012-07-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of S-equol administered twice daily (BID) for 14 days to healthy male and female subjects and to describe the pharmacokinetic profile of S-equol.

Conditions

  • Healthy

Interventions

DRUG

S-equol

oral, BID, 14 days

DRUG

Placebo

oral, BID, 14 days

Sponsors & Collaborators

  • Ausio Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Elizabeth Bianchi, MD · Syneos Health

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00998920 on ClinicalTrials.gov