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

Condition(s) targeted: Healthy

Intervention: Zonisamide (Drug); Zonegran (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Antonio R Pizarro, M.D, Principal Investigator, Affiliation: SFBC Ft. Myers, Inc

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 fasted subjects.

Official title: A Randomized. Single-Dose, Two-Way Crossover Relative Bioavailability Study of Zonisamide Formulations in Fasted Normal, Healthy Men and Women

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Bioequivalence on Cmax,AUC and Tmax Parameters

Detailed description: This was an open label, randomized, balanced, single dose, two-period, two-treatment, two-sequence crossover study, performed under fasting 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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?

SFBC Ft. Myers, Inc., Fort Myers, Florida 33901, United States

Starting date: January 2005
Last updated: July 13, 2010