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Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects

NCT01979380 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-08-12

No results posted yet for this study

Summary

To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects

To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects

To Evaluate the effect of food on bioavailability after KD101 single oral dosing in healthy male subjects

Conditions

  • Drug Toxicity

Interventions

DRUG

KD101

200mg (1casule), 600mg (3 capsule), 1000mg (5 capsule), 1400mg (7 capsule) PO, once in the morning

DRUG

placebo

PO, once in the morning

Sponsors & Collaborators

  • Kwang Dong Pharmaceutical co., ltd.

    lead INDUSTRY

Principal Investigators

  • Howard Lee, Professor · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • South Korea

Study Locations

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Entities

Drugs

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 NCT01979380 on ClinicalTrials.gov