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

NCT01581879 | Completed Phase 1 DMC

• 1 other identifier: 40350
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Ziprasidone hydrochloride; crossover

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  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

Study Arms (2)

Ziprasidone HCL Capsules, 20 mg

EXPERIMENTAL

Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Laboratories Limited

Drug: Ziprasidone Hydrochloride

Geodon Capsules, 20 mg

EXPERIMENTAL

Geodon Capsules, 20 mg of Pfizer Inc

Drug: Ziprasidone Hydrochloride

Interventions

Ziprasidone Hydrochloride DRUG

Ziprasidone HCL Capsules, 20 mg

Also known as: Geodon

Geodon Capsules, 20 mg; Ziprasidone HCL Capsules, 20 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

SFBC Ft. Myers, Inc.

Fort Myers, Florida, 33901, United States

Location

MeSH Terms

Interventions

ziprasidone

Study Officials

• Antonio R. Pizarro, MD

  SFBC Ft. Myers, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 20, 2012
• Study Start: November 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: January 1, 2005
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

US (1)