NCT03208218

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

An Open-label, Randomized, Single Dose, Crossover Bioequivalent Study to Compare Pharmacokinetic Property of SYP-1512 Tab and Revlimid Cap, 25mg in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Samyang Biopharmaceuticals Corporation · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Healthy volunteers are administrated single-dose over the period I and II (crossover) of SYP-1512 Tab and Revlimid cap (25mg) as of lenalidomide 25mg. Every time before and after each medication, pharmacokinetic (PK) parameters and safety of SYP-1512 Tab and Revlimid cap (25mg) is performed using a blood sample and conducting some tests (vital signs, physical exam, ECG, laboratory test, etc.) respectively

Conditions

• Healthy, Male

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-08-17
• Primary completion: 2016-08-25
• Completion: 2016-10-31
• First posted: 2017-07-05
• Last updated: 2017-07-06