At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 259 enrolled
Drug / intervention
Daprodustatdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Daprodustat for Anaemia. Completed, enrolled 259 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaemia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedNov 2020
Enrollment StartDec 2020
Primary CompletionMay 2021
TodayJul 2026
First PostedNov 23, 2020
Enrollment StartDec 18, 2020
Primary CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.6 years ago
Interventions
Daprodustatdrug
Daprodustat will be available as oral tablets.