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A Study in Evaluating Bioequivalence of Test and Reference Vadadustat 450 MG and 150 MG Tablets and to Determine Food Effect on the 450 MG Tablet

NCT03657290 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2019-03-22

No results posted yet for this study

Summary

This is a healthy volunteers study to assess the bioequivalence of vadadustat 450 mg tablets (Test A) compared to three 150mg tablets (Reference B). The study will also assess the effect of food on the bioavailability of vadadustat 450 mg tablet.

Conditions

  • Healthy

Interventions

DRUG

vadadustat

Vadadustat Tablets

Sponsors & Collaborators

  • Akebia Therapeutics

    lead INDUSTRY

Principal Investigators

  • Akebia Therapeutics · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2018-10-16
Completion
2018-10-16
FDA Drug
Yes

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 NCT03657290 on ClinicalTrials.gov