A study to compare the relative bioavailability of Fatak Chemie Pars and Eisai formulations of zonisamide 100 mg tablets in 24 healthy adult volunteers under fasting conditions

Fatak Chemie Pars Pharmaceuticals0 sites24 target enrollmentStarted: TBDLast updated: November 1, 2021

Conditions

Trial Snapshot

No summary available.

•18-55 years of age.
•The subject is able and willing to provide signed informed consent.
•The subject is available for the entire study period.
•Willing to adhere to protocol requirements as evidenced by written informed consent.
•The subject has a stable residence and telephone.
•Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.

•History of allergy or sensitivity to zonisamide.
•History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
•Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
•Presence of gastrointestinal disease or history of malabsorption within the last year.
•History of a medical disorders occurring within the last year that required hospitalization or medication.
•Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
•Receipt of any drug as part of a research study within 30 days prior to the present study.
•Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.

Sponsor

Fatak Chemie Pars Pharmaceuticals