Arterial Occlusive DiseasesPhase 1NCT02625714
Safety/Tolerability and Pharmacokinetic Study of SID142
A Phase 1 study testing Renexin® and SID142 in people with Arterial Occlusive Diseases, run by SK Chemicals Co., Ltd..
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 Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- Renexin® and SID142
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
- 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
- Hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
- Subject with a presence of gastroenteric disease or history of gastroenteric surgery which can influence the drug absorption
- Subject who has been seriously injured or received surgery or shown suspicious acute disease symptoms within 4 weeks of first administration.
- 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
- 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
- Participation in another clinical trial in the previous 3 months before first administration of this study
- Donation of whole blood in the previous 2 months or apheresis blood in the previous 1 month before first administration
- The subject with abnormal diet which can influence absorption, distribution, metabolism, and excretion of drug
- 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.
- 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)
About this study
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
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
- Being tested
- Renexin®, SID142
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renexin®Drug
Cilostazol 100mg/ginko biloba leaf extract 80mg, Immediate release, bid
SID142Drug
Cilostazol 200mg/ginko biloba leaf extract 160mg, Controlled release, qd
| Study group | Role | What they receive |
|---|---|---|
| A group | Other | Renexin® → SID142 Receives: Drug: Renexin®; Drug: SID142 |
| B group | Other | SID142 → Renexin® Receives: Drug: Renexin®; Drug: SID142 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC[Area under the concentration curve]τ,ss of Cilostazol
Total 68 time points during periods of both 1 and 2
Measured: During 144hours post-dose in each period
Cmax,ss of Cilostazol
Total 68 time points during periods of both 1 and 2
Measured: During 144hours post-dose in each period
Secondary outcomes (5)
AUClast,ss of Cilostazol
Total 68 time points during periods of both 1 and 2
Measured: During 144hours post-dose in each period
Tmax,ss of Cilostazol
Total 68 time points during periods of both 1 and 2
Measured: During 144hours post-dose in each period
CL[clearance]SS/F of Cilostazol
Total 68 time points during periods of both 1 and 2
Measured: During 144hours post-dose in each period
T1/2 of Cilostazol
Total 68 time points during periods of both 1 and 2
Measured: During 144hours post-dose in each period
Incidence rate of Adverse Events
Measured: During 25days from first administration of period 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Kyu Park, MD,PhD, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625714
- Sponsor's protocol ID
- SID142_BE_I_2015
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02625714
- Acronym / sponsor ID
- SID142_BE_I_2015
- Conditions
- Arterial Occlusive Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Other | Drug: Renexin®, Drug: SID142Renexin® → SID142 |
| B group | Other | Drug: Renexin®, Drug: SID142SID142 → Renexin® |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (26 listed)
- 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
- Subject with clinically significant findings on electrocardiogram[ECG] result during screening as stated below
- Active liver disease or inadequate laboratory result: AST[aspartate aminotransferase] , ALT[alanine aminotransferase] > 1.5 x upper limit of normal range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renexin®Cilostazol 100mg/ginko biloba leaf extract 80mg, Immediate release, bid | Drug | A group, B group |
| SID142Cilostazol 200mg/ginko biloba leaf extract 160mg, Controlled release, qd | Drug | A group, B group |
Primary outcome
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
5 secondary outcomes
AUClast,ss of Cilostazol
Time frame: During 144hours post-dose in each period
Tmax,ss of Cilostazol
Time frame: During 144hours post-dose in each period
CL[clearance]SS/F of Cilostazol
Time frame: During 144hours post-dose in each period
T1/2 of Cilostazol
Time frame: During 144hours post-dose in each period
Incidence rate of Adverse Events
Time frame: During 25days from first administration of period 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Kyu Park, MD,PhD principal investigator
Dong-A University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Renexin® and SID142 in people with Arterial Occlusive Diseases, run by SK Chemicals Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC[Area under the concentration curve]τ,ss of Cilostazol (time frame: During 144hours post-dose in each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.