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

Phase 1

Completed

• Conditions: Healthy, Male
• Interventions: Drug: SYP-1512; Drug: Revlimid cap

• Registration Number: NCT03208218
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief 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

Study Timeline

• Study Start: 2016-08-17
• Primary Completion: 2016-08-25
• Study Completion: 2016-10-31
• Study First Submitted: 2017-06-25
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-02
• Last Update Submitted: 2017-07-04
• Study First Posted: 2017-07-05
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

1. Over 20aged in healthy males
2. Those who do not have congenital or chronic diseases or pathological symptoms based on screening.
3. 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
4. BMI : 18-30
5. Those who have not donated blood within 2 weeks
6. Those without a history of gastrointestinal resection
7. Those who have no history of mental illness within the last 5 years
8. Agreement with written informed consent
9. Anyone who can follow and follow all scheduled admission and outpatient visits, dosing, clinical laboratory testing and subject compliance
10. 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
11. 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
12. Electrocardiogram (ECG) of the 12-electrode, QTc ≤ 450 msec
13. Those who have agreed not to donate blood or plasma and semen for at least 28 days after taking this drug
14. 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

1. Those taking drugs that significantly induce drug metabolizing enzymes within one month before screening (eg, barbiturate) or inhibit
2. Those taking medication that could affect the test within 10 days before screening
3. The person who is in charge of the examination of the medical institution (or the examining doctor who is delegated)
4. 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
5. Persons with hypersensitivity to venous puncture
6. 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)
7. Patients with severe hepatic impairment
8. Patients who are hypersensitive to NSAIDs and other components of NSAID
9. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
10. Patients with renal impairment (Cockcroft-Gault-type creatinine clearance <50 mL / min)
11. Positive result of Serum test [RPR Ab (VDRL), HBsAg, HCV Ab, anti HIV (AIDS)]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SYP-1512	SYP-1512	Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I\&II D1(crossover)
Revlimid cap.	Revlimid cap	Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I\&II D1(crossover)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg)	0-24hours	Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg)
Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg)	0-24hours	Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg)	0-inf	Bioequivalance of the AUCinf SYP-1512 and Revlimid cap (25mg)
Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg)	0-24hours	Bioequivalance of the Tmax of SYP-1512 and Revlimid cap (25mg)
Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg)	0-24hours	Bioequivalance of the T1/2 of SYP-1512 and Revlimid cap (25mg)