Status:
COMPLETED
Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Lead Sponsor:
Genovate Biotechnology Co., Ltd.,
Conditions:
Intermittent Claudication
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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-rel...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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;
- 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
- 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.
Key Trial Info
Start Date :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03480321
Start Date
March 6 2018
End Date
June 7 2018
Last Update
July 10 2018
Active Locations (1)
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1
Bio-Kinetic Clinical Applications, LLC
Springfield, Missouri, United States, 65802