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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: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02359045 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 137 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for EPA on baseline subtracted plasma concentrations.
Interventions
- DRUG D1400147
- DRUG D14000136
- DRUG D14000137
- DRUG Epanova®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2015-02-12 |
| Est. Completion | 2015-07-27 |
| Phase | Phase 1 |
What the finished NCT02359045 record still lists
NCT02359045 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher).
The record links to 0 conditions, and to 4 interventions - of which D1400147 is the first listed.
NCT02359045 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02359045's enrollment target sits among peer trials
137 420th of 2000 higher than 1,579 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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