Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions

Study Overview
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Brief Summary
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The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in subjects fed a high standard fat meal.

Detailed Description
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This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fed conditions. Subjects were confined to the SFBC Clinical Research Facility from at least 10 hours prior to drug administration, until after the 24-hour post-dose blood draw, in each period. The treatment phases were separated by a washout period of 28 days.

Official Title
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A Randomized. Single-Dose, Two-Way Crossover Relative Bioavailability Study of Zonisamide Formulations in Normal, Healthy Men and Women Following a Standard Meal

Conditions
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Healthy

Intervention / Treatment
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* Drug: Zonisamide
* Drug: Zonegran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Exclusion Criteria: Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day Period preceding study initiation?

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zonisamide<br>Zonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited | Drug: Zonisamide<br>* Zonisamide capsules 100 mg<br>* Other names: Zonegran Capsules 100 mg;|
| Active Comparator: Zonegran<br>Zonegran Capsules 100 mg of EISAI INC | Drug: Zonegran<br>* Zonegran Capsules 100 mg of EISAI INC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence on Cmax,AUC and Tmax Parameters |  | 3 months |