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Loratadine Under Fasting Conditions · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.) |
| 2 | EXPERIMENTAL | Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.) |
| 3 | ACTIVE_COMPARATOR | Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering) |
| Name | Type | Description |
|---|---|---|
| Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.) | DRUG | - |
| Loratadine 10 mg Tablets Under Fed Conditions (Sandoz, Inc.) | DRUG | - |
| Claritin (Loratadine) 10 mg Tablets Under Fed Conditions (Schering) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Loratadine Under Fasting Conditions is a Phase 1 clinical study formulation of loratadine 10 mg tablets developed by Novartis AG (ticker NVS). It is an investigational small molecule antihistamine evaluated for allergy under fasting conditions. The study assessed relative bioavailability of the 10 mg tablet compared with a reference product.
Loratadine Under Fasting Conditions is being studied for allergy. The Phase 1 trial enrolled healthy male volunteers aged 18 years and older to evaluate the drug under fasting conditions. It is an investigational formulation and has not been approved for any indication based on the available data.
Loratadine Under Fasting Conditions targets HRH1, the histamine H1 receptor, as an antagonist. By blocking HRH1, it is designed to reduce histamine-mediated allergic responses. This mechanism is consistent with its development for allergy in a Phase 1 bioavailability study.
Loratadine Under Fasting Conditions is developed by Novartis AG, which trades under the ticker NVS. The product is also known as Loratadine 10 mg Tablets Under Fasting Conditions (Sandoz, Inc.), reflecting the Sandoz association within the Novartis group.
Loratadine Under Fasting Conditions is in Phase 1 clinical development. The single registered trial, NCT00946608, has been completed. It is an investigational product and is not approved by the FDA for any indication based on the available information.
Loratadine Under Fasting Conditions has been evaluated in one completed Phase 1 trial, NCT00946608, titled "To Demonstrate the Relative Bioavailability Study of Loratadine 10 mg Tablets." The trial enrolled 30 healthy male volunteers, was randomized and active-controlled, and assessed the 10 mg tablet under fasting conditions.