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NCT04640311 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
259
Enrollment target

NCT04640311 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 259 participants.

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The verdict

NCT04640311, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
259 participants
Enrollment target

Study 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.

Interventions

  • DRUG Daprodustat

Trial Details

FieldValue
Enrollment Target 259 participants
Start Date 2020-12-18
Est. Completion 2021-05-18
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT04640311

The ClinicalTrials.gov registry entry for NCT04640311 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Daprodustat is the first listed.

NCT04640311 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04640311 about?

NCT04640311 is a clinical study titled "Comparison of Daprodustat Formulations Produced by Two Methods of Manufacture for Bioequivalence and Dissolution in Healthy Participants". 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 ...

What is the current status of trial NCT04640311?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 259 participants. The study started on 2020-12-18. Estimated completion is 2021-05-18.

What interventions are being tested in trial NCT04640311?

The interventions under investigation include: Daprodustat (DRUG).

Who is sponsoring clinical trial NCT04640311?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.