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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161966
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dr. Reddy's Laboratories Limited
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Vice president-Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01161966     History of Changes
Other Study ID Numbers: 40577
First Submitted: July 13, 2010
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
Last Verified: January 2005

Additional relevant MeSH terms:
Zonisamide
Anticonvulsants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs