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

Samyang Biopharmaceuticals Corporation

Status and phase

Completed

Phase 1

Conditions

Healthy, Male

Treatments

Drug: Revlimid cap

Drug: SYP-1512

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03208218

BIBE2016-02

Details and patient eligibility

About

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.

Full 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

Enrollment

42 patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Over 20aged in healthy males
Those who do not have congenital or chronic diseases or pathological symptoms based on screening.
The person who is determined to be the subject of the clinical laboratory test results such as hematology test, blood chemistry test, urine test, etc. set by the person in charge of the examination of the medical institution
BMI : 18-30
Those who have not donated blood within 2 weeks
Those without a history of gastrointestinal resection
Those who have no history of mental illness within the last 5 years
Agreement with written informed consent
Anyone who can follow and follow all scheduled admission and outpatient visits, dosing, clinical laboratory testing and subject compliance
If the partner is a woman of childbearing age who does not use the appropriate method of contraception (even if the man has undergone a vasectomy), while taking lenalidomide, during the interruption, for consenting to use condoms for 28 days after the last dose
In the vital sign measured in a sitting position, the systolic blood pressure ≤145 mmHg and ≥100 mmHg, the diastolic blood pressure ≤95 mmHg and ≥60 mmHg, the pulse rate> 40 and <100 times / minute
Electrocardiogram (ECG) of the 12-electrode, QTc ≤ 450 msec
Those who have agreed not to donate blood or plasma and semen for at least 28 days after taking this drug
If the contraceptive is withdrawn due to contraception or partner's pregnancy confirmation during testing. Those who agree to respond to follow-up within 6 months after pregnancy and after delivery

Exclusion criteria

Those taking drugs that significantly induce drug metabolizing enzymes within one month before screening (eg, barbiturate) or inhibit
Those taking medication that could affect the test within 10 days before screening
The person who is in charge of the examination of the medical institution (or the examining doctor who is delegated)
Those who have participated in the bioequivalence test or other clinical studies within 3 months prior to the administration of the test and administered the clinical trial drug
Persons with hypersensitivity to venous puncture
Screening Within the first 6 months, a person with a history of regular alcohol consumption as follows: 1 cup = 150 mL of wine or 360 mL of beer or 45 mL of distillate)
Patients with severe hepatic impairment
Patients who are hypersensitive to NSAIDs and other components of NSAID
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Patients with renal impairment (Cockcroft-Gault-type creatinine clearance <50 mL / min)
Positive result of Serum test [RPR Ab (VDRL), HBsAg, HCV Ab, anti HIV (AIDS)]