Trials / Completed
CompletedNCT00730912
Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)
Protocol for Post-approval Commitment Study of Loratadine for PPK Analysis in Japanese Pediatric and Adults Patients
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 3 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | loratadine | Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks |
| DRUG | loratadine | loratadine 10 mg tablet once daily for 4 weeks |
| DRUG | loratadine | loratadine 10 mg tablet once daily for 4 weeks |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-08-08
- Last updated
- 2017-04-13
- Results posted
- 2010-07-05
Source: ClinicalTrials.gov record NCT00730912. Inclusion in this directory is not an endorsement.