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