Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)
Completed
Merck Sharp & Dohme Corp.
2008-03-01
The purpose of this study is to collect information on unexpected adverse reactions (ADRs),
how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin
(loratadine) when used in children. Patients will be observed while they are taking Claritin,
and ADRs and symptom scores will be recorded. At the end of treatment, improvement in
symptoms will be recorded.
Post-marketing surveys are not considered applicable clinical trials and thus the results of
this survey will not be posted at its conclusion. The results will be submitted to public
health officials as required by applicable national and international laws.
Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions
Completed
Ranbaxy Laboratories Limited
N/A
2006-06-01
To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating
tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with
Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,
USA in healthy, adult, human male subjects under fasting condition.
Bioequivalence Study of Loratadine Orally Disintegrating Tablets 10 mg Under Fed Conditions
Completed
Ranbaxy Laboratories Limited
N/A
2006-07-01
To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating
tablets of Ohm Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals, Inc. USA) with
Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,
USA in healthy, adult, human male subjects under fed condition.
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