Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 45
Updated:7/12/2018
Start Date:March 6, 2018
End Date:June 7, 2018

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
1
site
Springfield, Missouri 65802
?
mi
from
Springfield, MO
Click here to add this to my saved trials