Cilostazol 100 mg Tablet Formulations Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00838630
First received: February 5, 2009
Last updated: September 1, 2009
Last verified: September 2009

February 5, 2009
September 1, 2009
November 2003
November 2003   (final data collection date for primary outcome measure)
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 96 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 96 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 96 hour period ] [ Designated as safety issue: No ]
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00838630 on ClinicalTrials.gov Archive Site
Not Provided
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Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
A Randomized, Two-Way, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Cilostazol, 100 mg, Compared to an Equivalent Dose of a Commercially Available Reference Drug Product in 36 Fasted, Healthy, Adult Subjects

The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36 adult subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Cilostazol 100 mg tablets
    1 x 100 mg
  • Drug: Pletal® 100 mg tablets
    1 x 100 mg
  • Experimental: 1
    Intervention: Drug: Cilostazol 100 mg tablets
  • Active Comparator: 2
    Intervention: Drug: Pletal® 100 mg tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2003
November 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Sex: Male and Female; similar proportion of each preferred. Female subjects must be surgically sterile for at least six (6) months or postmenopausal for at least one (1) year.
  • Age: At least 18 years.
  • Weight: Body Mass Index (BMI) of 30 or less.
  • Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory test, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:
  • Laboratory Tests:

Hemoglobin, hematocrit, RBC, WBC, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, and urinalysis. HIV, Hepatitis B, Hepatitis C, and drugs of abuse testing will be done for screening purposes only. Urine drugs of abuse testing will be repeated at each check-in. Female subjects will have a serum pregnancy test done at screening and a urine pregnancy test prior to each study period at check-in.

Laboratory values which are greater than 20% of the normal range will not qualify unless specifically accepted (with comment) by the Principal Investigator. Results of HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.

  • Electrocardiogram A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
  • Subjects must read and sign the Consent Form.

Exclusion Criteria:

  • History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months.
  • History of sensitivity to cilostazol, quinolones, or any antiplatelet drug.
  • History of malignancy, stroke, diabetes, cardiac, renal or liver disease or other serious illness.
  • History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
  • History of treatment for pulmonary obstruction or asthma within the past five (5) years.
  • History of severe headaches or migraines.
  • History of glaucoma.
  • History of chronic infectious disease.
  • History of psychiatric disorder.
  • History of thyroid disorder/disease.
  • History of hypertension.
  • Females who are capable of becoming pregnant or are lactating.
  • Inability to read and/or sign the consent form.
  • Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
  • Subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.
  • Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums, etc.). Three months abstinence is required.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00838630
03261
No
Not Provided
Teva Pharmaceuticals USA
Not Provided
Principal Investigator: Steven Herrmann, M.D., Ph. D. Cetero Research, San Antonio
Teva Pharmaceuticals USA
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP