Fed Bioavailability Study of Zonisamide Capsules

NCT00687167 | Completed Phase 1 Results

• 1 other identifier: R04-1377
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability (rate and extent of absorption) of a test formulation of zonisamide capsules compared to the reference formulation, Zonegran® (zonisamide)capsules, after a single oral dose administered under non-fasting conditions.

Conditions

Healthy

Keywords

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that the drug reaches in the plasma.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.

• Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]

  The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.

  serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 1, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11, 12, 14, 16, 24, 36, 48, 60 and 72 hours after drug administration.

Study Arms (2)

Zonisamide 100 mg Capsule

EXPERIMENTAL

A single dose of zonisamide 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast.

Drug: Zonisamide 100 mg Capsule

Zonisamide (Zonegran® ) 100 mg Capsule

EXPERIMENTAL

A single dose of Zonegran® 100 mg administered 30 minutes after initiation of a standardized, high fat breakfast.

Drug: Zonisamide (Zonegran®) 100 mg Capsule

Interventions

Zonisamide 100 mg Capsule DRUG

100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

Zonisamide 100 mg Capsule

Zonisamide (Zonegran®) 100 mg Capsule DRUG

100 mg capsule administered 30 minutes after initiation of standardized, high-fat breakfast.

Also known as: Zonegran®

Zonisamide (Zonegran® ) 100 mg Capsule

Eligibility Criteria

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

You may qualify if:

• Screening Demographics:
• All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing
• Weight range will not exceed ± 20% for height and body frame
• 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 observation, 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, Clinical Chemistry, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody, Urinalysis, Urine Drug Screen, Serum Pregnancy Screen, Follicle Stimulating Hormone
• If female: postmenopausal for 1 year or surgically sterile.

You may not qualify if:

• 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
• 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 reactive screen for hepatitis B surface antigen, hepatitis C antibody or 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 zonisamide or related drugs
• Volunteers with a history of clinically significant allergies including drug allergies
• Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigator)
• Volunteers who currently use tobacco products
• Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing
• Volunteers who report donating greater than 150mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study
• Volunteers who report receiving any investigational drug within 14 days prior to Period I dosing.
• 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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

PRACS

Fargo, North Dakota, 58104, United States

Location

Related Links

• Recalls, Market Withdrawals and Safety Alerts
• Daily Med - Posting of Recently Submitted Labeling to the FDA

MeSH Terms

Interventions

Zonisamide

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• James D Carlson, Pharm.D.

  PRACS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2008
• First Posted: May 30, 2008
• Study Start: January 1, 2005
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: January 26, 2010
• Results First Posted: December 30, 2009

Record last verified: 2010-01

Locations

US (1)