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Ondansetron

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 19, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Ondansetron · 2 trials · 1 indication

Phase 1 2
NCT01511705Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting ConditionHealthy
COMPLETED26 Analytics
NCT01511718Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed ConditionHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
Healthy
NCT0151170526
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PHASE1COMPLETED
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition
Healthy
NCT0151171826
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Study Endpoints

Primary Endpoints

Area unde curve (AUC)
First one was within 1 hour prior to drug administration (0.0) and others at 0.33,0.67,1,1.33, 1.67, 2, 2.5, 3, 3.5,4,6,9,12,15,18 and 24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ondansetron Hydrochloride Tablets 8 mgEXPERIMENTALOndansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited
Zofran Tablets 8 mgACTIVE_COMPARATORZofran Tablets 8 mg of GlaxoSmithKline

Interventions

NameTypeDescription
Ondansetron HydrochlorideDRUGOndansetron Hydrochloride Tablets 8 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who provide written informed consent. * Subjects who were healthy adults within 18 and 45 years of age (both inclusive). * Body mass index of ≥ 18 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg. * Subjects who had normal health as determined by medical his...

Countries:India
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Frequently asked questions about Ondansetron

What is Ondansetron used for?

Ondansetron is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies focused on bioequivalence of the 8 mg tablet formulation under fasting and fed conditions.

Who makes Ondansetron?

Ondansetron 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 to evaluate the bioequivalence of its ondansetron hydrochloride 8 mg tablets.

What phase is Ondansetron in?

Ondansetron is in Phase 1 clinical development. Two Phase 1 bioequivalence studies have been completed, both involving healthy volunteers in India. The drug is investigational and has not been approved for marketing based on the available clinical trial data.

What clinical trials is Ondansetron in?

Ondansetron has two completed Phase 1 clinical trials: NCT01511705, a bioequivalence study of ondansetron hydrochloride 8 mg tablets under fasting conditions, and NCT01511718, a similar study under fed conditions. Both trials enrolled 26 healthy volunteers each in India.

Is Ondansetron the same as ondansetron hydrochloride?

Ondansetron is the active ingredient in the drug product ondansetron hydrochloride. The clinical trials conducted by Dr. Reddy's Laboratories evaluate ondansetron hydrochloride tablets at an 8 mg dose, which contain ondansetron as the active pharmaceutical ingredient.