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| ID | Type | Description | Link |
|---|---|---|---|
| 1754415ALY1001 | Other Identifier | Xian-Janssen Pharmaceutical Ltd., China |
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The purpose of this study is to establish the relative bioavailability of Xisimin (loratadine) compared to Clarityne in healthy participants receiving a single dose of 10 milligram (mg) under fasting condition as part of Cohort 1 and under fed condition as part of Cohort 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Sequence 1 (ABAB) | Experimental | Participants will receive 10 milligram (mg) loratadine (1*10 mg oral tablet) as Xisimin (Treatment A) on Day 1 of Period 1 and Period 3 and 10 mg loratadine (1*10 mg oral tablet) administered as Clarityne (Treatment B) on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration. |
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| Cohort 1: Sequence 2 (BABA) | Experimental | Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fasted condition. A washout period of at least 7 days will be maintained between each treatment administration. |
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| Cohort 2: Sequence 1 (ABAB) | Experimental | Participants will receive Treatment A on Day 1 of Period 1 and Period 3 and Treatment B on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration. |
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| Cohort 2: Sequence 1 (BABA) | Experimental | Participants will receive Treatment B on Day 1 of Period 1 and Period 3 and Treatment A on Day 1 of Period 2 and Period 4 under fed condition. A washout period of at least 7 days will be maintained between each treatment administration. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loratadine (Xisimin [Test Treatment]) | Drug | Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability of Xisimin Compared With Clarityne | Bioavailability means the extent to which the active ingredient of a drug dosage form becomes available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. Relative bioavailability is the percentage of the administered dose that is systemically available, calculated as: (AUC [0-infinity] of test divided by AUC [0-infinity] of reference) multiplied by 100, where the reference treatment is a non-intravenous administration. | Cohort 1 and Cohort 2: Predose, 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Loratadine | The Cmax is the maximum observed plasma concentration. | Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose |
| Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) for Loratadine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service Genaral Hospital | Taipei | 11490 | Taiwan |
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| loratadine (Clarityne [Reference Treatment]) | Drug | Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence. |
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The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. |
| Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for Loratadine | The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Cohort 1 and Cohort 2: Predose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h postdose |
| Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. | From Screening to Day 5 of Period 4 (Approximately 54 days) |
| ID | Term |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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