GSK-207727

Study Sponsor: GSK

Study Title

A single centre, single dose, open-label, randomised, 2-way crossover study in healthy Japanese male subjects to evaluate the bioequivalence of daprodustat tablets (2 mg tablet vs. 4 mg tablet) (Part 1) and the food effect on the pharmacokinetics of daprodustat (Part 2)

Medicine or Vaccine (generic name)

daprodustat

Sponsor Identification Number

207727

Trial Registry Identification Number(#'s)

NCT03493386

Medical Condition

Anaemia

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=207727

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT03493386

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

The data for this study is available in CDISC format.

Date Added to this Site

May 2020