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

NCT03208218 | Completed Phase 1

• 1 other identifier: BIBE2016-02
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy, Male

Keywords

Evaluation of the pharmacokinetics equivalence; Healthy volunteers; Single dose over the period I and II(crossover); Healthy male volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pharmacokinetics of the AUCinf SYP-1512 and Revlimid cap (25mg)

  0-inf

• Pharmacokinetics of the Tmax of SYP-1512 and Revlimid cap (25mg)

  0-24hours

• Pharmacokinetics of the T1/2 of SYP-1512 and Revlimid cap (25mg)

  0-24hours

Study Arms (2)

SYP-1512

EXPERIMENTAL

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

Drug: SYP-1512

Revlimid cap.

ACTIVE COMPARATOR

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

Drug: Revlimid cap

Interventions

SYP-1512 DRUG

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

Also known as: Lenalidomide 25mg

SYP-1512

Revlimid cap DRUG

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

Also known as: Lenalidomide 25mg

Revlimid cap.

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \[RPR Ab (VDRL), HBsAg, HCV Ab, anti HIV (AIDS)\]

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead
• Chungnam National University Hospital: collaborator

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: July 5, 2017
• Study Start: August 17, 2016
• Primary Completion: August 25, 2016
• Study Completion: October 31, 2016
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share