Trials / Completed

CompletedNCT04640311

Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants

A Two-part, Randomized, Double-blind, Single-dose, Crossover Study to Compare Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Adult Volunteers

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 259 (actual)

Sponsor: GlaxoSmithKline · Industry
Sex: All
Age: 18 Years – 50 Years
Healthy volunteers: Accepted

Summary

This study is comprised of two discrete Parts. Part A is a 3-period cross over evaluating relative bioavailability. Part B is a 2-period cross over evaluating bioequivalence. There will be a minimum of a 7-day washout period between treatment periods. Participants will participate in Part A or Part B, but not both. Approximately 200 participants will be included in the study.

Conditions

Anaemia

Interventions

Type	Name	Description
DRUG	Daprodustat	Daprodustat will be available as oral tablets.

Timeline

Start date: 2020-12-18
Primary completion: 2021-05-18
Completion: 2021-05-18
First posted: 2020-11-23
Last updated: 2025-04-10
Results posted: 2023-01-26

Locations

4 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04640311. Inclusion in this directory is not an endorsement.