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The purpose of this study is to assess the bioequivalence of Zoloft ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasting condition with water in Healthy Japanese Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JZoloft | Active Comparator | Oral tablet of sertraline hydrochloride (Japanese commercial tablet: JZoloft ® tablet) 50 mg as a single oral dose under fasted conditions |
|
| ODT without water | Experimental | sertraline ODT 50 mg without water as a single oral dose under fasted conditions |
|
| ODT with water | Experimental | sertraline ODT 50 mg with water as a single oral dose under fasted conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZoloft | Drug | 50 mg tablet on Day 1 of each period |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC from zero to the last sampling point (AUCt) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions | 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | |
| Maximum plasma concentration (Cmax) of sertraline after dose of sertraline ODT 50 mg without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions | 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and AUCt of sertraline after dose of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions | 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | |
| Time of maximum plasma concentration of sertraline ODT 50 mg with water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hachioji-shi | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| sertraline ODT | Drug | 50 mg tablet on Day 1 of each period |
|
| sertraline ODT | Drug | 50 mg tablet on Day 1 of each period |
|
| 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| AUC from zero to infinity or last measurable concentration of sertraline after dose of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions | 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Terminal elimination rate constant (kel), half-life (t½) and mean residence time (MRT) of sertraline ODT 50 mg with and without water to Japanese commercial oral tablet of JZoloft 50 mg under fasted conditions | 0, 1, 2, 4, 6, 7, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Safety laboratory tests, vital signs, and adverse events (AEs) | From Periods 1 to 3 |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |