Peripheral Artery DiseasePhase 1NCT03524963
Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea
A Phase 1 study testing Cilostan CR Tab. and Pletaal SR Cap. in people with Peripheral Artery Disease, run by Bundang CHA Hospital at 1 site in South Korea.
Trial summary
This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Cilostan CR Tab. and Pletaal SR Cap.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Aug 2017to 30 Jun 2018
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 45 years
- BMI (body mass index) between 18.0 and 27.0
- Agreement with written informed consent
Who cannot join
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, ALT/AST/r-GTP/ALP/LDH/Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab
- Taking OTC (Over the counter) medicine including oriental medicine within 7 days
- Clinically significant allergic disease
- Subject with known for hypersensitivity reaction to Cilostazol
Show all 9Show fewer
- Previous whole blood donation within 60 days or component blood donation within 30 days
- Previous participation of other trial within 90 days
- Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Multiple Does, Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between Pleetal SR Cap. and Cilostan CR Tab. in Healthy Volunteers
This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers
Read the detailed description
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of CHA Bundang Medical Center on the day before dosing (Day -1).
From Day 1 to 5, Subjects will be dosed study drug (Pletaal SR Cap. 200 mg once a day or Cilostan CR Tab. 200mg once a day).
Pharmacokinetic samplings will be done upto 24 hours after 1st study drug dosing and upto 72 hours after 5th study drug dosing.
After 9 days of washout period (Day 15), Subjects will be dosed study drug and pharmacokinetic samplings will be done by crossover manner.
- Conditions
- Peripheral Artery Disease
- Being tested
- Cilostan CR Tab., Pletaal SR Cap.
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostan CR Tab.Drug
Cilostan CR Tab. 200mg once a day for 5 days
Pletaal SR Cap.Drug
Pletaal SR Cap. 200mg once a day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2 Receives: Drug: Cilostan CR Tab.; Drug: Pletaal SR Cap. |
| Sequence B | Experimental | Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2 Receives: Drug: Cilostan CR Tab.; Drug: Pletaal SR Cap. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximal plasma concentration
Measured: up to 24 hours after 1st dose
AUC0-24
Area under the time-concentration curve
Measured: up to 24 hours after 1st dose
Cmax,ss
Maximal plasma concentration at steady-state
Measured: up to 72 hours after 5th dose
AUCtau
Area under the time-concentration curve
Measured: up to 24 hours after 5th dose
Secondary outcomes (1)
AE
Adverse events
Measured: Up to 30 days after final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start7 Aug 2017
- Primary completion30 May 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doo-Yeoun Cho, M.D., Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524963
- Sponsor's protocol ID
- 021-402-00016
- Status last verified
- Jul 2018
- First submitted
- 1 May 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multiple Does, Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between Pleetal SR Cap. and Cilostan CR Tab. in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03524963
- Acronym / sponsor ID
- 021-402-00016
- Conditions
- Peripheral Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 15 May 2018 (actual)
- 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.
This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers
Detailed description
Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of CHA Bundang Medical Center on the day before dosing (Day -1).
From Day 1 to 5, Subjects will be dosed study drug (Pletaal SR Cap. 200 mg once a day or Cilostan CR Tab. 200mg once a day).
Pharmacokinetic samplings will be done upto 24 hours after 1st study drug dosing and upto 72 hours after 5th study drug dosing.
After 9 days of washout period (Day 15), Subjects will be dosed study drug and pharmacokinetic samplings will be done by crossover manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Cilostan CR Tab., Drug: Pletaal SR Cap.Cilostan CR Tab. in phase 1 and Pletaal SR Cap. in phase 2 |
| Sequence B | Experimental | Drug: Cilostan CR Tab., Drug: Pletaal SR Cap.Pletaal SR Cap. in phase 1 and Cilostan CR Tab. in phase 2 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged 20 - 45 years
- BMI (body mass index) between 18.0 and 27.0
- Agreement with written informed consent
Key exclusion criteria (9 listed)
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, ALT/AST/r-GTP/ALP/LDH/Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab
- Taking OTC (Over the counter) medicine including oriental medicine within 7 days
- Clinically significant allergic disease
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 |
|---|---|---|
| Cilostan CR Tab.Cilostan CR Tab. 200mg once a day for 5 days | Drug | Sequence A, Sequence B |
| Pletaal SR Cap.Pletaal SR Cap. 200mg once a day for 5 days | Drug | Sequence A, Sequence B |
Primary outcome
Cmax
Time frame: up to 24 hours after 1st dose
Maximal plasma concentration
AUC0-24
Time frame: up to 24 hours after 1st dose
Area under the time-concentration curve
Cmax,ss
Time frame: up to 72 hours after 5th dose
Maximal plasma concentration at steady-state
AUCtau
Time frame: up to 24 hours after 5th dose
Area under the time-concentration curve
1 secondary outcome
AE
Time frame: Up to 30 days after final dose
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 24 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cilostan CR Tab. and Pletaal SR Cap. in people with Peripheral Artery Disease, run by Bundang CHA Hospital at 1 site in South Korea.
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 3 inclusion and 9 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 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cmax (time frame: up to 24 hours after 1st dose). The study lists 4 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 24 Jul 2018.