Overview

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

Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Zonisamide
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?