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Tetrabenazine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Oct 18, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Tetrabenazine · 2 trials · 1 indication

Phase 1 2
NCT03702855Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed ConditionsHealthy
COMPLETED48 Analytics
NCT03696329Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting ConditionsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed Conditions
Healthy
NCT0370285548
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PHASE1COMPLETED
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions
Healthy
NCT0369632948
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Study Endpoints

Primary Endpoints

Area under curve
Pre-dose (within 1 hour prior to dosing), 0.33, 0.67, 1.00, 1.33, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 24.00 hours post dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tetrabenazine TabletsEXPERIMENTALTetrabenazine Tablets 25 mg of Dr. Reddy's Laboratories Limited
XenazineACTIVE_COMPARATORXenazine Tablets 25 mg of Lundbeck Inc.

Interventions

NameTypeDescription
Tetrabenazine Tablets 25 mgDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male and non pregnant female human subjects, age in the range of 18-45 years both inclusive. 2. Body mass index within the range of 18.5 kg/m2- 24.99 kg/m2 extremes included and body weight \> 50 kg. 3. Subjects with normal findings as determined by baseline history, physical...

Countries:India
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Frequently asked questions about Tetrabenazine

What is Tetrabenazine used for?

Tetrabenazine is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated in bioequivalence studies to compare the effects of Tetrabenazine tablets under fasting and fed conditions.

Who makes Tetrabenazine?

Tetrabenazine 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 clinical trials to evaluate the drug in healthy volunteers.

What phase is Tetrabenazine in?

Tetrabenazine is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 96 participants enrolled. The drug is investigational and has not been approved for any indication.

What clinical trials is Tetrabenazine in?

Tetrabenazine has two completed Phase 1 trials. NCT03696329 is a bioequivalence study of Tetrabenazine tablets 25 mg under fasting conditions with 48 participants. NCT03702855 is a bioequivalence study under fed conditions with 48 participants. Both trials were conducted in India.

Is Tetrabenazine FDA approved?

Tetrabenazine is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trials were bioequivalence studies in healthy volunteers, and the drug has not progressed to later-stage trials or regulatory approval.