Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Loratadine oral solution
Loratadine · 3 trials · 2 indications
Area under the curve from time 0 to the last measurable concentration.
Maximum observed plasma level
Area under the concentration versus time curve from zero to the last data point greater than (\>) LLOQ (AUC\[0-tlast\]) after single dose.
Maximum observed loratadine concentration in plasma, directly taken from analytical data.
| Arm | Type | Description |
|---|---|---|
| Test treatment | EXPERIMENTAL | Healthy adult subjects under fed conditions |
| Reference treatment | ACTIVE_COMPARATOR | Healthy adult subjects under fed conditions |
| Loratadine oral solution/syrup then Claritin peach syrup | EXPERIMENTAL | Subjects received a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments. |
| Claritin peach syrup then Loratadine oral solution/syrup | EXPERIMENTAL | Subjects received a single oral dose of 10 mg loratadine-claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in treatment period 1, followed by a single oral dose of 10 mg loratadine-oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in treatment period 2. A wash-out period of at least 10 calendar days was maintained between the 2 treatments. |
| Name | Type | Description |
|---|---|---|
| Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG) | DRUG | Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1) |
| Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist) | DRUG | Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1) |
| Loratadine oral solution | DRUG | Subjects received a single oral dose of 10 mg loratadine oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in any intervention period. |
| Loratadine (Claritin peach syrup) | DRUG | Subjects received a single oral dose of 10 mg loratadine claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in any intervention period. |
Inclusion Criteria: * Healthy adult men or women * Age 18 to 55 years inclusive * Body mass index 18.5 to 30.0 kg/m\*2 inclusive * Be willing and able to consume all contents of the standardized breakfast within 30 minutes of dosing Exclusion Criteria: * Positive alcohol or drug screen at Screeni...
Loratadine is a small molecule histamine H1 receptor antagonist developed by Bayer AG (ticker BAYRY). It is a non-sedating antihistamine studied in clinical pharmacology and histamine H1 antagonist research. Bayer's clinical development work on loratadine formulations is at Phase 1, with completed bioequivalence studies in healthy adult volunteers.
Loratadine targets HRH1, the histamine H1 receptor, acting as an antagonist. By blocking this receptor, loratadine belongs to the non-sedating histamine H1 antagonist class. Its development program with Bayer AG (BAYRY) focuses on clinical pharmacology studies of different loratadine formulations.
Bayer AG, which trades under the ticker BAYRY, is the developer associated with the loratadine programs described here. Bayer conducted Phase 1 bioequivalence studies of loratadine oral solution and Claritin-D extended release tablets, including manufacturing transfer comparisons.
Loratadine is in Phase 1 clinical development in the programs described here. Both completed trials are Phase 1 bioequivalence studies, and no active trials are listed. The studies enrolled healthy adult volunteers and evaluated different loratadine formulations.
Loratadine has been studied in completed Phase 1 trials including NCT03517943 and NCT03517930, which compared the bioequivalence of Claritin-D 12-hour extended release tablets from two manufacturers under fed and fasted conditions, and NCT02593747, which assessed loratadine oral solution versus Claritin peach syrup.