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A Ph 1 Study of Epanova® in Healthy Chineses

NCT03574142 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-07-05

No results posted yet for this study

Summary

The purpose of this study is to explore the safety, tolerability, and PK of single and multiple doses of Epanova in healthy male and female Chinese subjects and to allow comparison of these parameters with the Western population studied to date.

Conditions

  • Healthy Subjects

Interventions

DRUG

Epanova

A single dose of Epanova 4 g will be administered as 4 capsules (each containing 1 g of Epanova) followed by a 72-hour washout period in Chinese healthy subjects. Subsequently, multiple doses of Epanova 4 g will be administered once daily for 14 consecutive days.

Sponsors & Collaborators

Principal Investigators

  • Yang Lin, MD · Beijing Anzhen Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2018-06-27
Completion
2018-06-27

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574142 on ClinicalTrials.gov