Trials / Completed
CompletedNCT03517930
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
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 Fasted Conditions in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2018-04-17
- Primary completion
- 2018-07-20
- Completion
- 2018-07-20
- First posted
- 2018-05-08
- Last updated
- 2018-09-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03517930. Inclusion in this directory is not an endorsement.