NCT03517943View on ClinicalTrials.gov

A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

August 30, 2018

Study Completion Date

August 30, 2018

Conditions
Clinical Pharmacology
Interventions
DRUG

Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)

Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)

DRUG

Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)

Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)

Trial Locations (1)

07094

Frontage Clinical Services, Secaucus

Sponsors

Lead Sponsor

Bayer
All Listed Sponsors
lead

Bayer

INDUSTRY