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

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.

Study Overview

• Status: Completed
• Conditions: Healthy, Male
• Intervention / Treatment: Drug: SYP-1512; Drug: Revlimid cap

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SYP-1512; Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)	Drug: SYP-1512; Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover); Other Names: Lenalidomide 25mg
ACTIVE_COMPARATOR: Revlimid cap.; Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover)	Drug: Revlimid cap; Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover); Other Names: Lenalidomide 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of the AUCt between SYP-1512 and Revlimid cap(25mg)	Bioequivalance of the AUCt between SYP-1512 and Revlimid cap(25mg)	0-24hours
Pharmacokinetics of the Cmax between SYP-1512 and Revlimid cap(25mg)	Bioequivalance of the Cmax between SYP-1512 and Revlimid cap(25mg)	0-24hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Collaborators: Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2016
• Primary Completion (ACTUAL): August 25, 2016
• Study Completion (ACTUAL): October 31, 2016

Study Registration Dates

• First Submitted: June 25, 2017
• First Submitted That Met QC Criteria: July 2, 2017
• First Posted (ACTUAL): July 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 4, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Healthy volunteers; Healthy male volunteers; Evaluation of the pharmacokinetics equivalence; Single dose over the period I and II(crossover)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: BIBE2016-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No