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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 45
Updated:3/8/2019
Start Date:February 11, 2019
End Date:April 2019

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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.


Inclusion Criteria:

- 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) within normal standard limits (18.5 -24.9, 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.

Exclusion Criteria:

- 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.

- 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.

- 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
twelve (12) months of spontaneous amenorrhea with serum Follicle Stimulating
Hormone (FSH) levels > 40IU/L, OR;

2. Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy,
OR;

3. 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.
We found this trial at
1
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Springfield, Missouri 65802
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Springfield, MO
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