Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01581879
First received: April 19, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

The objective of this study is to compare the rate and extent of absorption of ziprasidone 20 mg capsules versus Geodon 20 mg capsules under fed conditions.


Condition Intervention Phase
Healthy
Drug: Ziprasidone Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, 2-way Crossover, Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg in Healthy Subjects Under Fed Conditions.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Area under curve (AUC) [ Time Frame: 1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 6.50, 7, 8, 9, 10, 12, 16, 24 and 36 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 2004
Study Completion Date: January 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ziprasidone HCL Capsules, 20 mg
Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Laboratories Limited
Drug: Ziprasidone Hydrochloride
Ziprasidone HCL Capsules, 20 mg
Other Name: Geodon
Experimental: Geodon Capsules, 20 mg
Geodon Capsules, 20 mg of Pfizer Inc
Drug: Ziprasidone Hydrochloride
Ziprasidone HCL Capsules, 20 mg
Other Name: Geodon

Detailed Description:

Randomized, 2-way crossover, bioequivalence study of Ziprasidone 20 mg capsules and Geodon 20 mg capsules in healthy subjects under fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, smoker or non-smoker, 18 years of age and older.
  • Capable of consent.
  • BMI between 19.0 and 30.0 kg/m2 inclusively.

Exclusion Criteria:

  • Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
  • Positive testing for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less than 60 or over 100 bpm) at screening.
  • Qtc > 430 for males and Qtc > 450 for females.
  • History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
  • Regular use of alcohol within six months prior to the screening visit ( more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
  • Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • History of allergic reaction to heparin, ziprasidone, or other related drugs.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazole, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms(e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of clinically significant neurological endocrinal cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
  • Difficulty to swallow study medication.
  • Smoking more than 25 cigarettes per day.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows.

    1. 50 mL to 300 mL of whole blood within 30 days,
    2. 301 mL to 500 mL of whole blood within 45 days, or
    3. more than 500 mL of whole blood within 56 days prior to drug administration.
  • Consumption of food or beverages containing grapefruit (e.g. fresh, canned, or frozen) within 7 days prior to administration of the study medication.
  • History or known presence of tardive dyskinesia.
  • History of neuroleptic malignant syndrome.
  • History or known presence of clinically significant cardiac diseases (such as heart failure, QT prolongation, congenital long QT syndrome, myocardial infarction, cardiac arrhythmias, conduction abnormalities) or other conditions such as electrolyte disturbance, hypokalemia or hypomagnesemia.
  • Breast-feeding subject.
  • Positive urine pregnancy test at screening.
  • Female subjects of childbearing potential having unprotected sexual intercourse with any non-steril male partner (i.e male who has not been sterilized by vasectomy for at least 6 months ) within 14 days prior to study drug administration. Acceptable methods of contraception.

    1. intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;
    2. condom or diaphragm + spermicide;
    3. hormonal contraceptives (starting at least 4 weeks prior to study drug administration.
  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: NCT01581879

Locations
United States, Florida
SFBC Ft. Myers, Inc.
Fort Myers, Florida, United States, 33901
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Antonio R. Pizarro, MD SFBC Ft. Myers, Inc
  More Information

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01581879     History of Changes
Other Study ID Numbers: 40350
Study First Received: April 19, 2012
Last Updated: April 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Ziprasidone hydrochloride
crossover

Additional relevant MeSH terms:
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014