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The main objective is to compare the pharmacokinetics in single dose, and effect of food on the trazodone hydrochloride pharmacokinetics prolonged-release tablets.
Trial I single dose (75mg and 150mg), fasting or postprandial comparative pharmacokinetics of trazodone hydrochloride prolonged-release tablets and ordinary formulation; 16 patients (males and females, half and half).
Trial is a 4-period, 4 cross (4x4) Williams crossover design, screened 16 subjects (half males and half females) were randomly divided into four groups (I-1, I-2, I-3, I-4), each 2 men and 2 women, give the following four different crossover treatments:
(A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) Time for drug administration is around 8:00am. Wash-out period is 7 days. Blood sampling will be performed before (0h) and after administration each dose group 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0h.
Trial I. 4X4 Williams design Group Period 1 Period 2 Period 3 Period 4 I-1 A D B C I-2 B A C D I-3 C B D A I-4 D C A B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-1 | Experimental | This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; |
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| I-2 | Experimental | This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) |
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| I-3 | Experimental | This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trazodone Hydrochloride prolonged-release tablets | Drug | strength 75mg, 150 mg. Oral administration with 200ml water |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) | To observe area under curve characteristics of trazodone hydrochloride prolonged-release tablets in single or multiple dose groups | pre-dose, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration |
| Area Under Curve (AUC) | To observe area under curve characteristics of trazodone hydrochloride prolonged-release tablets in fasting or high-fat diet groups | pre-dose, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration |
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Inclusion Criteria:
Exclusion Criteria:
Any of the abnormalities of ECGs examination occurs in screening period or the first day of administration:
Life style:
Others:
The female subjects are not eligible for inclusion in this study if she meet any of the following criteria above and below:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea On Yan Luk | Prince of Wales Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| I-4 | Experimental | This is a four different crossover treatments with 2 men and 2 women, give the following treatment sequence, with wash out period 7 days (D) postprandial single oral trazodone hydrochloride tablets 150mg (50mg for 3 times) (C) fasting single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; (A) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 75 mg; (B) postprandial single oral dose of trazodone hydrochloride prolonged-release tablets 150 mg; |
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