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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01161966
First received: July 13, 2010
Last updated: NA
Last verified: January 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Zonisamide
Drug: Zonegran
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized. Single-Dose, Two-Way Crossover Relative Bioavailability Study of Zonisamide Formulations in Fasted Normal, Healthy Men and Women

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence on Cmax,AUC and Tmax Parameters [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: January 2005
Study Completion Date: March 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zonisamide
Zonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited
Drug: Zonisamide
Zonisamide capsules 100 mg
Other Name: Zonegran Capsules 100 mg
Active Comparator: Zonegran
Zonegran Capsules 100 mg of EISAI INC
Drug: Zonegran
Zonegran Capsules 100 mg of EISAI INC

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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?
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161966

Locations
United States, Florida
SFBC Ft. Myers, Inc.
Fort Myers, Florida, United States, 33901
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Antonio R Pizarro, M.D SFBC Ft. Myers, Inc
  More Information

No publications provided

Responsible Party: Vice president-Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01161966     History of Changes
Other Study ID Numbers: 40577
Study First Received: July 13, 2010
Last Updated: July 13, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Zonisamide
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014