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Crossover Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap in Healthy Male Volunteers

NCT03208218 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-07-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics equivalence and safety by comparing pharmacokinetics characteristics between the SYP-1512 Tab and Revlimid cap (25mg) when administered a single-dose to healthy male volunteers.

Conditions

  • Healthy, Male

Interventions

DRUG

SYP-1512

Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)

DRUG

Revlimid cap

Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I\&II D1(crossover)

Sponsors & Collaborators

  • Chungnam National University Hospital

    collaborator OTHER

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2016-08-17
Primary Completion
2016-08-25
Completion
2016-10-31

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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 NCT03208218 on ClinicalTrials.gov