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Study to Evaluate a Pharmacokinetic of HM61713 in Healthy Male Subjects

NCT01894399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-12-15

No results posted yet for this study

Summary

Study Design

* Open, escalating single-dose design.
* 7 ascending dose cohorts
* In each cohorts, subjects will receive a single dose of HM61713.
* Main objective of this study is to evaluate the pharmacokinetics of HM61713 tablet.

Conditions

  • Healthy Volunteers

Interventions

DRUG

HM61713

Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • In-Jin Jang, MD PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • South Korea

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 NCT01894399 on ClinicalTrials.gov