To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup

PHASE1CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

January 31, 2016

Study Completion Date

March 31, 2016

Conditions
Histamine H1 Antagonists, Non-Sedating
Interventions
DRUG

Loratadine oral solution

Subjects received a single oral dose of 10 mg loratadine oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in any intervention period.

DRUG

Loratadine (Claritin peach syrup)

Subjects received a single oral dose of 10 mg loratadine claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in any intervention period.

Trial Locations (1)

89231

Neu-Ulm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY