Cilostazol 50 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00839930
First received: February 6, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd. and distributed by TEVA Pharmaceuticals USA with that of PLETAL Tablets manufactured by Otsuka Pharmaceuticals Co., Ltd. for Otsuka America Pharmaceutical, Inc. following a single oral dose (1 x 50 mg tablet) in healthy adult subjects administered under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Cilostazol 50 mg Tablets
Drug: Pletal®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 50 mg Cilostazol Tablets Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration [ Time Frame: Blood samples collected over 72 hour period ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2004
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cilostazol (test)
Cilostazol 50 mg Tablet (test) dosed in first period followed by Pletal® 50 mg Tablet (reference) dosed in second period
Drug: Cilostazol 50 mg Tablets
1 x 50 mg, single-dose fasting
Active Comparator: Pletal® (reference)
Pletal® 50 mg Tablet (reference) dosed in first period followed by Cilostazol 50 mg Tablet (test) dosed in second period.
Drug: Pletal®
1 x 50 mg, single-dose tablet

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screening Demographics: All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The volunteer's body mass index (BMI) is less than or equal to 30.
  • Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.

Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems.

  • The screening clinical laboratory procedures will include:

    • Hematology: hematocrit, hemoglobin, RBC count, WBC count with differential, platelet count;
    • Clinical Chemistry: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase.
    • HIV antibody and hepatitis B surface antigen and hepatitis C antibody screens;
    • Urinalysis: by dipstick; full microscopic examination if dipstick positive; and
    • Urine Drug Screen: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, and phencyclidine;
    • Serum Pregnancy Screen (female volunteers only).
    • Follicle Stimulating Hormone (FSH; female subjects only): verify postmenopausal status
  • If female and:

    • is postmenopausal for at least 1 year with postmenopausal status defined as: > 60 years of age and amenorrheic for at least one year; if 60 years of age or younger, must also have a serum FSH level >30 IU/L; or
    • is surgically sterile for at least 6 months (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  • Volunteers with a recent history of drug or alcohol addiction or abuse.
  • Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
  • Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
  • Volunteers demonstrating a positive drug abuse screen when screened for this study.
  • Female volunteers demonstrating a positive pregnancy screen.
  • Female volunteers who are currently breastfeeding.
  • Volunteers with a history of allergic response(s) to cilostazol or related drugs.
  • Volunteers with a history of clinically significant allergies including drug allergies.
  • Volunteers with a clinically significant illness during 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Volunteers who are currently using or report using tobacco products within 90 days prior to Period I dosing.
  • Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
  • Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  • Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  • Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
  • Volunteers who report taking any prescription medication or nonprescription medication in the 14 days or 7 days, respectively, prior to Period I dosing with the exception of topical products without systemic absorption.
  • Volunteers who have been on an abnormal diet during the 28 days prior to Period I dosing.
  • Volunteers who report an intolerance or direct venipuncture.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839930

Locations
United States, Minnesota
PRACS Institute Ltd.
East Grand Forks, Minnesota, United States, 56721
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D. Carlson, Pharm.D. PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00839930     History of Changes
Other Study ID Numbers: R04-099
Study First Received: February 6, 2009
Results First Received: June 18, 2009
Last Updated: September 1, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Cilostazol
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 20, 2014