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Fexofenadine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 28, 2013

Target and mechanism

ModalitySmall molecule

Also known as Fexofenadine Hydrochloride

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials5
Total Enrollment246

FDA Designations

No designations recorded

Clinical trial landscape

Fexofenadine · 5 trials · 1 indication

Phase 1 5
NCT01888718Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting ConditionHealthy
COMPLETED80 Analytics
NCT01133483Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed ConditionsHealthy
COMPLETED38 Analytics
NCT01133470Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting ConditionsHealthy
COMPLETED54 Analytics
NCT01066754Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting ConditionsHealthy
COMPLETED44 Analytics
NCT01066767Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed ConditionsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Healthy
NCT0188871880
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PHASE1COMPLETED
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions
Healthy
NCT0113348338
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PHASE1COMPLETED
Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions
Healthy
NCT0113347054
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PHASE1COMPLETED
Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Healthy
NCT0106675444
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PHASE1COMPLETED
Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Healthy
NCT0106676730
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Study Endpoints

Primary Endpoints

Area under curve (AUC)
Pre-dose (0.0) and 0.167, 0.33, 0.50, 0.75, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.50, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 hrs
Bioequivalence based on Cmax and AUC parameters
2 months
Bioequivalence study of Dr. Reddys, Fexofenadine Hydrochloride 180 mg tablets
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Fexofenadine Hydrochloride Orally DisintegratingEXPERIMENTALFexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr.Reddy's Laboratories Ltd
ALLEGRAACTIVE_COMPARATORALLEGRA orally disintegrating tablets 30 mg of Sanofi Aventis
Fexofenadine HCl + Pseudoephedrine HClEXPERIMENTALFexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories
Allegra-D 24 hour ER TabletsACTIVE_COMPARATORAllegra-D 24 hour ER Tablets of Aventis Pharmaceuticals INC., USA.
FexofenadineEXPERIMENTALFexofenadine Hydrochloride 180 mg Tablets of Dr. Reddy's Laboratories Limited

Interventions

NameTypeDescription
Fexofenadine HydrochlorideDRUGFexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
Fexofenadine HCl + Pseudoephedrine HClDRUGFexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories Limited
FexofenadineDRUGFexofenadine Hydrochloride 180 mg Tablets
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: i. Provide written informed consent. ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2. iv. Must be of ...

Countries:IndiaCanada
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