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

NCT01161979 | Completed Phase 1

• 1 other identifier: 40578
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence on Cmax,AUC and Tmax Parameters

  3 months

Study Arms (2)

Zonisamide

EXPERIMENTAL

Zonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited

Drug: Zonisamide

Zonegran

ACTIVE COMPARATOR

Zonegran Capsules 100 mg of EISAI INC

Drug: Zonegran

Interventions

Zonisamide DRUG

Zonisamide capsules 100 mg

Also known as: Zonegran Capsules 100 mg

Zonisamide

Zonegran DRUG

Zonegran Capsules 100 mg of EISAI INC

Zonegran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?

You may not qualify if:

• 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?

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

SFBC Ft. Myers, Inc.

Fort Myers, Florida, 33901, United States

Location

MeSH Terms

Interventions

Zonisamide

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Antonio R Pizarro, M.D

  SFBC Ft. Myers, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: January 1, 2005
• Primary Completion: February 1, 2005
• Study Completion: March 1, 2005
• Last Updated: July 14, 2010

Record last verified: 2005-01

Locations

US (1)