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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-173774 | Other Identifier | Japic |
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To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).
To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC-01 in period 1, Aripiprazole and sertraline in period 2 | Experimental | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. |
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| Aripiprazole and sertraline in period 1, ASC-01 in period 2 | Experimental | At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. |
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| Fasting in period 1, After breakfast in period 2 | Experimental | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast. |
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| After breakfast in period 1, Fasting in period 2 | Experimental | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered 30 minutes after the start of breakfast. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) will be administered after 10 or more hours of fasting. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC-01 | Drug | Aripiprazole 3 mg/sertraline 100 mg combination drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1 | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing | |
| Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1 | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing | |
| Cmax of Aripiprazole and Sertraline in Cohort 2 | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing | |
| AUC168h of Aripiprazole and Sertraline in Cohort 2 | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Kyusyu Region | Fukuoka | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: ASC-01 First | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting. There was a washout period of at least 35 days between Period I and Period II. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2017 | Apr 4, 2021 |
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| Aripiprazole and sertraline | Drug | Aripiprazole 3 mg and sertraline 100 mg |
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| FG001 |
| Cohort 1: Aripiprazole/Sertraline Concomitant First |
At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. There was a washout period of at least 35 days between Period I and Period II. |
| FG002 | Cohort 2: ASC-01 Under Fasted First | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast. There was a washout period of at least 35 days between Period I and Period II. |
| FG003 | Cohort 2: ASC-01 Under Fed First | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. There was a washout period of at least 35 days between Period I and Period II. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Set: subjects who received investigational medicinal product (IMP) at least once.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: ASC-01 First | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. At Day 1 in Period II, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting. There was a washout period of at least 35 days between Period I and Period II. |
| BG001 | Cohort 1: Aripiprazole/Sertraline Concomitant First | At Day 1 in Period I, Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. There was a washout period of at least 35 days between Period I and Period II. |
| BG002 | Cohort 2: ASC-01 Under Fasted First | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast. There was a washout period of at least 35 days between Period I and Period II. |
| BG003 | Cohort 2: ASC-01 Under Fed First | At Day 1 in Period I, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast. At Day 1 in Period II, ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. There was a washout period of at least 35 days between Period I and Period II. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Peak Plasma Concentration (Cmax) of Aripiprazole in Cohort 1 | Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing |
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| Primary | Area Under the Plasma Concentration Versus Time Curve 168h (AUC168h) of Aripiprazole in Cohort 1 | Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained. | Posted | Mean | Standard Deviation | ng*h/mL | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing |
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| Primary | Cmax of Aripiprazole and Sertraline in Cohort 2 | Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing |
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| Primary | AUC168h of Aripiprazole and Sertraline in Cohort 2 | Pharmacokinetic Analysis Set comprised subjects who received IMP and for whom plasma drug concentration data were obtained. | Posted | Mean | Standard Deviation | ng*h/mL | Baseline, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72,96, 144 and 168h after dosing |
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Treatment-emergent adverse events occurring up to 8 days after dosing date were collected.
Safety Set comprised subjects who received IMP at least once.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - ASC-01 | ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. | 0 | 52 | 0 | 52 | 44 | 52 |
| EG001 | Cohort 1 - Aripiprazole/Sertraline Concomitant | Aripiprazole 3 mg and sertraline 100 mg was administered after 10 or more hours of fasting. | 0 | 52 | 0 | 52 | 43 | 52 |
| EG002 | Cohort 2 - ASC-01 Under Fasted | ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered after 10 or more hours of fasting. | 0 | 20 | 0 | 20 | 12 | 20 |
| EG003 | Cohort 2 - ASC-01 Under Fed | ASC-01 (aripiprazole 3 mg/sertraline 100 mg combination drug) was administered 30 minutes after the start of breakfast. | 0 | 20 | 0 | 20 | 14 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA Ver. 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2018 | Apr 4, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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