Healthy
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGZonisamide
Zonisamide capsules 100 mg
DRUGZonegran
Zonegran Capsules 100 mg of EISAI INC
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence on Cmax,AUC and Tmax Parameters | 3 months |
Countries
United States
Outcome results
None listed