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| ID | Type | Description | Link |
|---|---|---|---|
| 2017ZX09309012 | Other Grant/Funding Number | Ministry of Science and Technology of China |
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This study will investigate the tolerability and pharmacokinetics of Hypidone Hydrochloride by multiple doses in 36 healthy male and female subjects who are of 18 to 55 years old.
This is a double-blind, placebo-controlled, randomized, multiple-dose, single center study. 36 male and female healthy subjects will be enrolled in this study. Within 14 days prior to study drug administration, subjects will be screened based on the inclusion and exclusion criteria. The study will be performed in 3 groups of 12 subjects each. In each group of 12 subjects, 10 subjects will be randomly assigned to receive Hypidone Hydrochloride and 2 subjects to receive matching placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypidone Hydrochloride 60mg | Experimental | 30mg(10mg×3) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8. |
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| Hypidone Hydrochloride 80mg | Experimental | 40mg(10mg×4) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8. |
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| Hypidone Hydrochloride 100mg | Experimental | 50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8. |
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| Placebo 60mg | Placebo Comparator | 3 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8. |
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| Placebo 80mg | Placebo Comparator | 4 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8. |
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| Placebo 100mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypidone Hydrochloride tablets | Drug | 30mg(10mg×3), 40mg(10mg×4) or 50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak Plasma Concentration | Day 1-11 |
| Tmax | Time to Peak Plasma Concentration | Day 1-11 |
| AUC | Area under the plasma concentration versus time curve | Day 1-11 |
| T1/2 | half-life | Day 1-11 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with treatment-emergent adverse events(TEAE) | Clinical significant Abnormal of Laboratory valuse, physical examination results, vital signs and ECG results will be recorded as TEAE. | Up to Day 15 |
| Percentage of subjects with abnormal Laboratory values |
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Inclusion Criteria:
Exclusion Criteria:
The ratio of male and female is 1:1.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Placebo Comparator |
5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8. |
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| Placebo | Drug | 3, 4 or 5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8. |
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Laboratory tests including Hematology, Biochemistry and Urinalysis. |
| Up to Day 15 |
| Percentage of subjects with abnormal Physical examinations results | Physical examinations including Head and face, skin system, lymph nodes, eyes, ear, nose and throat, mouth, respiratory system, abdomen, cardiovascular system, musculoskeletal and nervous system. | Up to Day 15 |
| Percentage of subjects with abnormal Vital signs results | Vital signs including sitting blood pressure, pulse rate and ear temperature. | Up to Day 15 |
| Percentage of subjects with abnormal ECG(12-lead Electrocardiogram) results | ECG tests including heart rates, PR interval, QT interval, corrected QT interval. | Up to Day 15 |