Cilostazol 100 mg Tablet Formulations Under Fasting Conditions

NCT00838630 | Completed Phase 1 Results

• 1 other identifier: 03261
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 96 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 96 hour period

• AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration

  Bioequivalence based on AUC0-t

  Blood samples collected over 96 hour period

Study Arms (2)

1

EXPERIMENTAL

Drug: Cilostazol 100 mg tablets

2

ACTIVE COMPARATOR

Drug: Pletal® 100 mg tablets

Interventions

Cilostazol 100 mg tablets DRUG

1 x 100 mg

1

Pletal® 100 mg tablets DRUG

1 x 100 mg

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Gateway Medical Research Inc.

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

Cilostazol

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Steven Herrmann, M.D., Ph. D.

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: November 1, 2003
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: August 19, 2024
• Results First Posted: July 21, 2009

Record last verified: 2024-08

Locations

US (1)