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NCT02359045 · ClinicalTrials.gov registry record · Phase 1

Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
137
Enrollment target

NCT02359045 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 137 participants.

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The verdict

NCT02359045, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
137 participants
Enrollment target

Study Summary

This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of the study is to compare the pharmacokinetics (PK) of three different prototype capsule formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be used as basis for choice of formulation for further pharmaceutical development.

Interventions

  • DRUG D1400147
  • DRUG D14000136
  • DRUG D14000137
  • DRUG Epanova®

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2015-02-12
Est. Completion 2015-07-27
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT02359045

The ClinicalTrials.gov registry entry for NCT02359045 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 137 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 4 interventions - of which D1400147 is the first listed.

NCT02359045 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02359045 about?

NCT02359045 is a clinical study titled "Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions". This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of the study is to compare the pharmacokinetics (PK) of three different prototype capsule formulations (omega-3-carboxy...

What is the current status of trial NCT02359045?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2015-02-12. Estimated completion is 2015-07-27.

What interventions are being tested in trial NCT02359045?

The interventions under investigation include: D1400147 (DRUG), D14000136 (DRUG), D14000137 (DRUG), Epanova® (DRUG).

Who is sponsoring clinical trial NCT02359045?

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.