Clinical trial NCT03480321: Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Official title: An Open-Label, Randomized, Three-Treatment, Three-Way Crossover Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intermittent Claudication
Keywords: Peripheral Artery Disease
Cilostazol
PMR
Extended-Release Tablet of Cilostazol
Lead sponsor: Genovate Biotechnology Co., Ltd.,
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the bioequivalency between the test formulations 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.


Eligibility criteria: Inclusion Criteria:

* Must be 18 to 45 years of age, inclusive.
* Absence of diseases, such as heart failure, significant kidney impairment or a history of restricted blood flow to the heart, that could affect the study outcomes.
* Having a body mass index (BMI) within normal standard limits (18.5\~24.9, inclusive).
* Willing and able to give informed consent to participate in the clinical study and comply with all study procedures, restrictions and attend all visits.

Exclusion Criteria:

* History of bleeding tendency.
* Use of anticoagulant agent(s) within 1 month prior to screening.
* Use of tobacco or nicotine products within 6 months of screening.
* Intake of over the counter or prescription drugs (other than hormonal contraceptives) within 2 weeks prior to randomization.
* On any investigational drug(s) or therapeutic device(s) within 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 1 year prior to screening.
* Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
* 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:

  1. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than 12 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels \> 40IU/L, OR;
  2. 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
  3. Using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation), hormonal contraception (e.g. implantable, injectable, vaginal patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation.
* Known or suspected hypersensitivity to any ingredient of study drug(s).
* Donated blood or lost more than 150 mL of blood within 3 months prior to randomization or plans to donate blood or plasma within 4 weeks after completion of the study.

Primary outcomes:
measure: Area under the curve, from time zero to last measureable time point (AUC (0-t))
timeFrame: 0-72 hours after morning dose
measure: AUC from time zero to infinity (AUC (0-∞))
timeFrame: 0-72 hours after morning dose
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC
state: Missouri
Study officials:
References: