Safety/Tolerability and Pharmacokinetic Study of SID142

NCT02625714 | Completed Phase 1

• 1 other identifier: SID142_BE_I_2015
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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

Conditions

Arterial Occlusive Diseases

Outcome Measures

Primary Outcomes (2)

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

  Total 68 time points during periods of both 1 and 2

  During 144hours post-dose in each period

• Cmax,ss of Cilostazol

  Total 68 time points during periods of both 1 and 2

  During 144hours post-dose in each period

Secondary Outcomes (5)

• AUClast,ss of Cilostazol

  During 144hours post-dose in each period

• Tmax,ss of Cilostazol

  During 144hours post-dose in each period

• CL[clearance]SS/F 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

Study Arms (2)

A group

OTHER

Renexin® → SID142

Drug: Renexin®; Drug: SID142

B group

OTHER

SID142 → Renexin®

Drug: Renexin®; Drug: SID142

Interventions

Renexin® DRUG

Cilostazol 100mg/ginko biloba leaf extract 80mg, Immediate release, bid

A group; B group

SID142 DRUG

Cilostazol 200mg/ginko biloba leaf extract 160mg, Controlled release, qd

A group; B group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subject who was given and completely understood full explanation about the study, decided to participate in the study and signed written informed consent willingly.

You may not qualify if:

• 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
• Subject with clinically significant findings on electrocardiogram\[ECG\] result during screening as stated below
• QTc \> 450 ms
• PR interval \> 200 msec
• QRS duration \> 120 msec
• Active liver disease or inadequate laboratory result: AST\[aspartate aminotransferase\] , ALT\[alanine aminotransferase\] \> 1.5 x upper limit of normal range

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

MeSH Terms

Conditions

Arterial Occlusive Diseases

Interventions

renexin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Min Kyu Park, MD,PhD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

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: December 4, 2015
• First Posted: December 9, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12