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Assessment of 2012 Bioequivalence Standards for Warfarin

NCT02574754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-08-05

No results posted yet for this study

Summary

The purpose of this study is to assess the 2012 bioequivalence statistical criteria for warfarin, a narrow therapeutic index drug, set forth in the draft guidance issued by the Food and Drug Administration (FDA).

Conditions

  • Healthy

Interventions

DRUG

warfarin

warfarin 10 mg PO x 1

Sponsors & Collaborators

Principal Investigators

  • Leslie Z Benet, PhD · University of California, San Francisco

  • Lynda A Frassetto, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02574754 on ClinicalTrials.gov