Clinical Trials/NCT02625714

NCT02625714

Completed

Phase 1

A Randomized, Open-label, Oral Multiple Dosing, Two-way Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Profiles of SID142 in Healthy Volunteers

SK Chemicals Co., Ltd.0 sites41 target enrollmentJune 2015

ConditionsArterial Occlusive Diseases

InterventionsRenexin®SID142

DrugsRenexin®SID142

Overview

Phase: Phase 1
Intervention: Renexin®
Conditions: Arterial Occlusive Diseases
Sponsor: SK Chemicals Co., Ltd.
Enrollment: 41
Primary Endpoint: AUC[Area under the concentration curve]τ,ss of Cilostazol
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

A randomized, open-label, oral multiple dosing, two-part, two-way crossover clinical trial to evaluate the safety/tolerability and pharmacokinetic profiles of SID142 in healthy volunteers

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

July 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

SK Chemicals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adult aged between 19 and 45
•Weights more than 50Kg , BMI between 18.5 and 25.0 kg/m2
•Subject without congenital or chronic disease requiring medical treatment and any pathological symptoms or opinion according to internal examination
•Subject with acceptable laboratory result and ECG result
•Negative result to blood serum human chorionic gonadotropin\[hCG\] pregnancy test at screening and urine hCG pregnancy test prior to administration in female subject. In addition, at least one condition should be corresponded which is stated below
•Menopause(no menstruation for at least 2 years)
•surgically sterile (hysterectomy or both oophorectomy, tubal ligation or other method)
•Male partner should be sterile(confirmed as aspermia after deferentectomy) and sole before screening.
•Woman who agreed to use proper method of conception accurately and continuously from at least 14 days before first Investigational Product\[IP\] administration to at least 30days after dosing.
•Male subject should use contraception(condom) during clinical trial and maintain contraception and agree not to donate sperm until 28days after last dosing.

Exclusion Criteria

•Female subject who is pregnant or breast-feeding
•Person who has anaphylaxis for IP component or clinically significant medical history of anaphylaxis for other drugs
•Subject with a clinically significant medical history of disease on liver, kidney, nervous system, respiratory system, endocrine system, blood tumor, urinary system, cardiovascular system, musculoskeletal system or psychiatric disorder or others below
•severe nephrotic disorder
•moderate or severe hepatic disorder
•menstruation period
•aortocoronary stenosis complication
•disease or predisposition of bleeding
•congestive heart failure or arrhythmia
•diabetes mellitus or glucose tolerance disorder

Arms & Interventions

A group

Renexin® → SID142

Intervention: Renexin®

A group

Renexin® → SID142

Intervention: SID142

B group

SID142 → Renexin®

Intervention: Renexin®

B group

SID142 → Renexin®

Intervention: SID142

Outcomes

Primary Outcomes

AUC[Area under the concentration curve]τ,ss of Cilostazol

Time Frame: During 144hours post-dose in each period

Total 68 time points during periods of both 1 and 2

Cmax,ss of Cilostazol

Time Frame: During 144hours post-dose in each period

Total 68 time points during periods of both 1 and 2

Secondary Outcomes

Tmax,ss of Cilostazol(During 144hours post-dose in each period)
CL[clearance]SS/F of Cilostazol(During 144hours post-dose in each period)
AUClast,ss of Cilostazol(During 144hours post-dose in each period)
T1/2 of Cilostazol(During 144hours post-dose in each period)
Incidence rate of Adverse Events(During 25days from first administration of period 1)