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NCT01682408 · ClinicalTrials.gov registry record · Phase 1

Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
28
Enrollment target

NCT01682408 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 28 participants.

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The verdict

NCT01682408, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target

Study Summary

Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

Interventions

  • DRUG Ranitidine
  • DRUG Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)
  • DRUG Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
  • DRUG Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
  • DRUG Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2012-09
Est. Completion 2012-12
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01682408

The ClinicalTrials.gov registry entry for NCT01682408 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Ranitidine is the first listed.

NCT01682408 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01682408 about?

NCT01682408 is a clinical study titled "Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability". Study to Assess the Pharmacokinetics of R406 in Healthy Subjects when Fostamatinib 150 mg is Administered Alone in Fed and Fasted state and in Combination with Ranitidine in Fasted State, and to Assess the Relative Bioavailability of Process Variants of Tablets

What is the current status of trial NCT01682408?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2012-09. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01682408?

The interventions under investigation include: Ranitidine (DRUG), Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference) (DRUG), Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed (DRUG), Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A) (DRUG), Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B) (DRUG).

Who is sponsoring clinical trial NCT01682408?

This trial is sponsored by AstraZeneca, which has 1,285 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.