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ALLEGRA

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

ALLEGRA · 2 trials · 1 indication

Phase 1 2
NCT00835276Fexofenadine Hydrochloride 180 mg Tablets Under Fasting ConditionsHealthy
COMPLETED60 Analytics
NCT00835640Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting ConditionsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax = Maximum Observed Concentration.
Blood samples collected over a 48 hour period.

Bioequivalence based on Cmax.

AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant)
Blood samples collected over a 48 hour period.

Bioequivalence based on AUC0-t.

AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
Blood samples collected over a 48 hour period.

Bioequivalence based on AUC0-inf.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Fexofenadine 180 mg tabletsDRUG1 x 180 mg
ALLEGRA® 180 mg tabletsDRUG1 x 180 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * All volunteers selected for this study will be healthy, non-smoking men and women 18 to 55 years of age, inclusive, at the time of dosing. The volunteer's body mass index (BMI) is less that or equal to 30. * If female and : * of child bearing potential, is practicing an acc...

Countries:United States
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Frequently asked questions about ALLEGRA

What is ALLEGRA used for?

ALLEGRA is an investigational small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical trials, which are studying the drug in healthy volunteers. The trials are not focused on treating a specific disease, but rather on evaluating the drug's pharmacokinetics under fasting and non-fasting conditions.

Who makes ALLEGRA?

ALLEGRA is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. 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. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ALLEGRA in?

ALLEGRA has two completed Phase 1 clinical trials. NCT00835276 studied fexofenadine hydrochloride 180 mg tablets under fasting conditions with 60 participants. NCT00835640 studied the same tablets under non-fasting conditions with 24 participants. Both trials were conducted in the United States with healthy volunteers aged 18 years and older.

Is ALLEGRA the same as fexofenadine hydrochloride?

Yes, ALLEGRA is the same as fexofenadine hydrochloride. The clinical trials for ALLEGRA are specifically titled 'Fexofenadine Hydrochloride 180 mg Tablets,' indicating that the drug's active ingredient is fexofenadine hydrochloride. This is the generic name for the medication.