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

NCT ID: NCT03208218

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-17
• Study Completion Date: 2016-10-31

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

Conditions

Healthy, Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SYP-1512

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

Group Type: EXPERIMENTAL

SYP-1512

Intervention Type: DRUG

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

Revlimid cap.

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

Group Type: ACTIVE_COMPARATOR

Revlimid cap

Intervention Type: DRUG

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

Interventions

SYP-1512

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

Intervention Type: DRUG

Revlimid cap

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

Intervention Type: DRUG

Other Intervention Names

Lenalidomide 25mg; Lenalidomide 25mg

Eligibility Criteria

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)]

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chungnam National University Hospital

OTHER

Sponsor Role: collaborator

Samyang Biopharmaceuticals Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BIBE2016-02

Identifier Type: -

Identifier Source: org_study_id