NCT03517930View 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 Manufacturers Under Fasted Conditions in Healthy Adult Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

April 17, 2018

Primary Completion Date

July 20, 2018

Study Completion Date

July 20, 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