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Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers

NCT01444677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-21

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and tolerability of MB12066 after a single or multiple oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single or multiple oral dose.

Conditions

Interventions

DRUG

MB12066

MB12066 300mg

DRUG

MB12066

MB12066 400mg

DRUG

MB12066

MB12066 100mg

DRUG

MB12066

MB12066 200mg

DRUG

Placebo

Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)

Sponsors & Collaborators

  • KT&G Corporation

    collaborator INDUSTRY

  • Yungjin Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyung-Sang Yu, Professor · Clinical Research Institute of Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

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 NCT01444677 on ClinicalTrials.gov