Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
|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.|
|ClinicalTrials.gov Identifier: NCT01161979|
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : July 14, 2010
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Zonisamide Drug: Zonegran||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||March 2005|
Zonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited
Zonisamide capsules 100 mg
Other Name: Zonegran Capsules 100 mg
Active Comparator: Zonegran
Zonegran Capsules 100 mg of EISAI INC
Zonegran Capsules 100 mg of EISAI INC
- Bioequivalence on Cmax,AUC and Tmax Parameters [ Time Frame: 3 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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?
- 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?
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): NCT01161979
|United States, Florida|
|SFBC Ft. Myers, Inc.|
|Fort Myers, Florida, United States, 33901|
|Principal Investigator:||Antonio R Pizarro, M.D||SFBC Ft. Myers, Inc|
|Responsible Party:||Vice president-Research & Development, Dr. Reddy's Laboratories Limited|
|Other Study ID Numbers:||
|First Posted:||July 14, 2010 Key Record Dates|
|Last Update Posted:||July 14, 2010|
|Last Verified:||January 2005|
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs