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Clinical trial

A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5 mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-Heist) Under Fed Conditions in Healthy Adult Subjects

NCT03517943 is registered in ClinicalTrials.gov with Bayer as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5 mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-Heist) Under Fed Conditions in Healthy Adult Subjects
Lead sponsor
Bayer
Phase
Phase 1
Overall status
Completed
Start date
April 24, 2018
Completion date
August 30, 2018
Enrollment
29 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

clinical pharmacology