Recent Updates
Recently added Catalysts

Zonisamide

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 14, 2010

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Zonisamide · 2 trials · 1 indication

Phase 1 2
NCT01161966Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting ConditionsHealthy
COMPLETED26 Analytics
NCT01161979Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed ConditionsHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence on Cmax,AUC and Tmax Parameters
3 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZonisamideEXPERIMENTALZonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited
ZonegranACTIVE_COMPARATORZonegran Capsules 100 mg of EISAI INC

Interventions

NameTypeDescription
ZonisamideDRUGZonisamide capsules 100 mg
ZonegranDRUGZonegran Capsules 100 mg of EISAI INC
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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 responsibilit...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Zonisamide

What is Zonisamide used for?

Zonisamide is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical trials, but these trials are conducted in healthy volunteers, not for a specific disease. The studies are bioequivalence trials comparing Zonisamide capsules 100 mg under fasting and fed conditions.

Who makes Zonisamide?

Zonisamide is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 clinical trials for this drug, which are bioequivalence studies in healthy volunteers.

What phase is Zonisamide in?

Zonisamide is in Phase 1 clinical development. There are two completed Phase 1 trials, both bioequivalence studies in healthy volunteers. The drug is investigational and not yet approved for any indication, as it is still in early-stage clinical development.

What clinical trials is Zonisamide in?

Zonisamide has two completed Phase 1 clinical trials: NCT01161966, a bioequivalence study of Zonisamide capsules 100 mg under fasting conditions, and NCT01161979, a similar study under fed conditions. Both trials enrolled 26 healthy volunteers each in the United States.

Is Zonisamide the same as other drugs?

Zonisamide is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. No alternative names for this drug have been mentioned in the available information. It is being studied in Phase 1 bioequivalence trials, which compare the drug's performance to a reference product.