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Allegra

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Allegra · 2 trials · 1 indication

Phase 1 2
NCT00647985Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mgHealthy
COMPLETED28 Analytics
NCT00649376Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mgHealthy
COMPLETED68 Analytics
PHASE1COMPLETED
Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFexofenadine Tablets 180 mg
2ACTIVE_COMPARATORAllegra® Tablets 180 mg

Interventions

NameTypeDescription
Fexofenadine Tablets 180 mgDRUG180mg, single dose fed
Allegra® Tablets 180 mgDRUG180mg, single dose fed
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Eligibility Criteria

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

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening...

Countries:United States
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Frequently asked questions about Allegra

What is Allegra?

Allegra is a small molecule drug being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers for research purposes, with two completed Phase 1 trials involving a total of 96 participants.

What is Allegra used for?

Allegra is being studied in healthy volunteers for research purposes. It is currently in Phase 1 clinical development, and the completed trials were conducted in the United States with participants aged 18 years and older. The drug is not yet approved for any specific medical condition.

Who makes Allegra?

Allegra is being developed by Viatris Inc., a company traded on the stock exchange under the ticker VTRS. The drug is currently in Phase 1 clinical development, with two completed trials in healthy volunteers.

What phase is Allegra in?

Allegra is in Phase 1 clinical development. It is an investigational drug, meaning it is still being studied and has not been approved for medical use. Two Phase 1 trials have been completed, both involving healthy volunteers.

What clinical trials is Allegra in?

Allegra has been studied in two completed Phase 1 clinical trials: NCT00647985, a food study of fexofenadine tablets 180 mg and Allegra tablets 180 mg with 28 participants, and NCT00649376, a fasting study with 68 participants. Both trials were conducted in the United States with healthy volunteers.

Is Allegra the same as fexofenadine?

Allegra is being studied in comparison with fexofenadine tablets in clinical trials. The trials are designed to evaluate the effects of Allegra tablets 180 mg against fexofenadine tablets 180 mg under food and fasting conditions. The drug is currently in Phase 1 development.