Safety/Tolerability and Pharmacokinetic Study of SID142

Arterial Occlusive Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625714
• Other study ID #: SID142_BE_I_2015
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2015
• Last updated: December 10, 2015
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy adult aged between 19 and 45

2. Weights more than 50Kg , BMI between 18.5 and 25.0 kg/m2

3. Subject without congenital or chronic disease requiring medical treatment and any pathological symptoms or opinion according to internal examination

4. Subject with acceptable laboratory result and ECG result

5. 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.

6. Male subject should use contraception(condom) during clinical trial and maintain contraception and agree not to donate sperm until 28days after last dosing.

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

Exclusion Criteria:

1. Female subject who is pregnant or breast-feeding

2. Person who has anaphylaxis for IP component or clinically significant medical history of anaphylaxis for other drugs

3. 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

4. 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

5. Active liver disease or inadequate laboratory result: AST[aspartate aminotransferase] , ALT[alanine aminotransferase] > 1.5 x upper limit of normal range

6. At screening, subject with clinically significant vital signs(sitting position blood pressure): Systolic blood pressure >140 mmHg or < 90 mmHg, diastolic pressure > 90 mmHg or < 60 mmHg

7. Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome

8. Subject with a presence of gastroenteric disease or history of gastroenteric surgery which can influence the drug absorption

9. Subject who has been seriously injured or received surgery or shown suspicious acute disease symptoms within 4 weeks of first administration.

10. Consumption of excessive alcohol continuously or the subject who cannot quit drinking within 3 days prior to IP administration and during clinical trial period or subject who smokes

11. A history of taking any ETC drugs[Ethical drugs], oriental medicine within 2 weeks or OTC drugs[Over-the-Counter drugs] within 1week prior to first administration

12. Participation in another clinical trial in the previous 3 months before first administration of this study

13. Donation of whole blood in the previous 2 months or apheresis blood in the previous 1 month before first administration

14. The subject with abnormal diet which can influence absorption, distribution, metabolism, and excretion of drug

15. Consumption of food which can influence drug metabolism or caffeine within 48 hours after the first administration, or the subject who cannot quit consumption of such foods during whole study period.

16. Positive results to serum tests (HBsAg[hepatitis B surface antigen], anti-HCV Ab[hepatitis C virus antibody], anti-HIV Ab[human immunodeficiency virus antibody], VDRL[Venereal Disease Research Laboratory] test)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Drug:
• Renexin®
Cilostazol 100mg/ginko biloba leaf extract 80mg, Immediate release, bid
• SID142
Cilostazol 200mg/ginko biloba leaf extract 160mg, Controlled release, qd

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC[Area under the concentration curve]t,ss of Cilostazol	Total 68 time points during periods of both 1 and 2	During 144hours post-dose in each period	No
Primary	Cmax,ss of Cilostazol	Total 68 time points during periods of both 1 and 2	During 144hours post-dose in each period	No
Secondary	AUClast,ss of Cilostazol	Total 68 time points during periods of both 1 and 2	During 144hours post-dose in each period	No
Secondary	Tmax,ss of Cilostazol	Total 68 time points during periods of both 1 and 2	During 144hours post-dose in each period	No
Secondary	CL[clearance]SS/F of Cilostazol	Total 68 time points during periods of both 1 and 2	During 144hours post-dose in each period	No
Secondary	T1/2 of Cilostazol	Total 68 time points during periods of both 1 and 2	During 144hours post-dose in each period	No
Secondary	Incidence rate of Adverse Events		During 25days from first administration of period 1	Yes