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Investigation of Arrhythmogenic Effect of NPC-15 (NPC-15-7)

NCT03475459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-06-28

No results posted yet for this study

Summary

A study to assess the QTc prolongation effect of NPC-15 (melatonin 8mg or 16mg)

Conditions

  • Qt Interval, Variation in

Interventions

DRUG

NPC-15 and/or Placebo

The dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg)

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Principal Investigators

  • Masaharu Hayashi, MD, PhD · Shukutoku University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2018-04-29
Completion
2018-04-29

Countries

  • Japan

Study Locations

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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 NCT03475459 on ClinicalTrials.gov