Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
This study has been completed.
Sponsor:
Dr. Reddy's Laboratories Limited
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01161979
First received: July 13, 2010
Last updated: NA
Last verified: January 2005
History: No changes posted
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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 subjects fed a high standard fat meal.
| 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 Normal, Healthy Men and Women Following a Standard Meal |
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 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.
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: NCT01161979
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: | NCT01161979 History of Changes |
| Other Study ID Numbers: | 40578 |
| 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 May 16, 2013