Intermittent ClaudicationPhase 1NCT05466734
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
A Phase 1 study testing Cilostazol Tablet 100 mg and PMR Tablet 135 mg in people with Intermittent Claudication, run by Genovate Biotechnology Co., Ltd., at 1 site in United States.
Trial summary
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate- release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Cilostazol Tablet 100 mg and PMR Tablet 135 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 20 Sep 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be 18 to 45 years of age, inclusive, at screening.
- Absence of diseases that could affect the study outcomes.
- Having a body mass index (BMI) between 18.5 and 29.9, inclusive, at screening.
- Females must have a negative serum pregnancy test at screening.
- Understanding and willing to participate in the clinical study and able to comply with study procedures and visits.
Who cannot join
- History of bleeding tendency.
- Use of anticoagulant agent(s) within one (1) month prior to screening.
- Use of tobacco or nicotine products within six (6) months of screening.
- Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization.
- On any investigational drug(s) or therapeutic device(s) within thirty (30) days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
- History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within one (1) year prior to screening.
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- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); known history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three (3) months of screening.
- Positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at any time during the study, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19).
- Pregnant or breast feeding.
- Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
- Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than twelve (12) months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;
- Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
- Are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (e.g. implantable, injectable, vaginal, patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for seven (7) days after study discontinuation.
- Known or suspected hypersensitivity to any ingredient of the study drug(s).
- Donated blood or lost more than 150 mL of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (4) weeks after completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, 65802
About this study
Official title: An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate- release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.
- Conditions
- Intermittent Claudication
- Being tested
- Cilostazol Tablet 100 mg, PMR Tablet 135 mg
- Keywords
- Peripheral Artery Disease, Cilostazol, PMR, Extended-Release Tablet of Cilostazol
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol Tablet 100 mgDrug
Also called Treatment R
Two oral doses (total daily dose of 200 mg)
PMR Tablet 135 mgDrug
Also called Treatment T
Single oral dose (total daily dose of 270 mg)
| Study group | Role | What they receive |
|---|---|---|
| Treatment RTRT (R: Cilostazol, T: PMR) | Other | Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00
Treatment T: Two PMR Tablet 135 mg at 08:00
Four-period dosing following the sequence of Treatment RTRT Receives: Drug: Cilostazol Tablet 100 mg; Drug: PMR Tablet 135 mg |
| Treatment TRTR (T: PMR, R: Cilostazol) | Other | Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00
Treatment T: Two PMR Tablet 135 mg at 08:00
Four-period dosing following the sequence of Treatment TRTR Receives: Drug: Cilostazol Tablet 100 mg; Drug: PMR Tablet 135 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve, from time zero to last measureable time point (AUC 0-t )
Measured: 0-72 hours after morning dose
AUC from time zero to infinity (AUC 0-∞)
Measured: 0-72 hours after morning dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start5 Jul 2022
- Primary completion23 Aug 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kayce Morton, Principal investigator, Bio-Kinetic Clinical Applications, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466734
- Sponsor's protocol ID
- GBL22-001
- Status last verified
- Apr 2023
- First submitted
- 18 Jul 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05466734
- Acronym / sponsor ID
- GBL22-001
- Conditions
- Intermittent Claudication
- Keywords
- Peripheral Artery Disease, Cilostazol, PMR, Extended-Release Tablet of Cilostazol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Genovate Biotechnology Co., Ltd.,Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 20 Jul 2022 (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.
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate- release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment RTRT (R: Cilostazol, T: PMR) | Other | Drug: Cilostazol Tablet 100 mg, Drug: PMR Tablet 135 mgTreatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment RTRT |
| Treatment TRTR (T: PMR, R: Cilostazol) | Other | Drug: Cilostazol Tablet 100 mg, Drug: PMR Tablet 135 mgTreatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment TRTR |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be 18 to 45 years of age, inclusive, at screening.
- Absence of diseases that could affect the study outcomes.
- Having a body mass index (BMI) between 18.5 and 29.9, inclusive, at screening.
- Females must have a negative serum pregnancy test at screening.
- Understanding and willing to participate in the clinical study and able to comply with study procedures and visits.
Key exclusion criteria (15 listed)
- History of bleeding tendency.
- Use of anticoagulant agent(s) within one (1) month prior to screening.
- Use of tobacco or nicotine products within six (6) months of screening.
- Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization.
- On any investigational drug(s) or therapeutic device(s) within thirty (30) days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
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 |
|---|---|---|
| Cilostazol Tablet 100 mgAlso: Treatment RTwo oral doses (total daily dose of 200 mg) | Drug | Treatment RTRT (R: Cilostazol, T: PMR), Treatment TRTR (T: PMR, R: Cilostazol) |
| PMR Tablet 135 mgAlso: Treatment TSingle oral dose (total daily dose of 270 mg) | Drug | Treatment RTRT (R: Cilostazol, T: PMR), Treatment TRTR (T: PMR, R: Cilostazol) |
Primary outcome
Area under the curve, from time zero to last measureable time point (AUC 0-t )
Time frame: 0-72 hours after morning dose
AUC from time zero to infinity (AUC 0-∞)
Time frame: 0-72 hours after morning 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 13 Apr 2023.
Related trials for Intermittent Claudication
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Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
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Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Improving Mobility After Revascularization in Peripheral Artery Disease
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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.
Kayce Morton principal investigator
Bio-Kinetic Clinical Applications, LLC
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 Cilostazol Tablet 100 mg and PMR Tablet 135 mg in people with Intermittent Claudication, run by Genovate Biotechnology Co., Ltd., at 1 site in United States.
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 5 inclusion and 15 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 13 Apr 2023. 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 United States. 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?
Area under the curve, from time zero to last measureable time point (AUC 0-t ) (time frame: 0-72 hours after morning dose). 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 13 Apr 2023.