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| ID | Type | Description | Link |
|---|---|---|---|
| B4Z-JE-LYEO | Other Identifier | Eli Lilly and Company |
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To demonstrate the bioequivalence of 12.5 milliliters (mL) of atomoxetine oral solution (4 milligrams per milliliter [mg/mL]) compared with 2 capsules of atomoxetine (25 mg per capsule) in healthy adult male Japanese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine Oral Solution | Experimental |
| |
| Atomoxetine Capsule Formulation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | Administered orally, once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject. | Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] | The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject. | Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fukuoka | 810-0064 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine Oral Solution First, Then Capsule Formulation | Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters [mL] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. |
| FG001 | Atomoxetine Capsule Formulation First, Then Oral Solution | Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine Oral Solution First, Then Capsule Formulation | Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. |
| BG001 | Atomoxetine Capsule Followed by Oral Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) | The Cmax values are based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject. | All participants who had a Cmax value were included in the Cmax analysis. | Posted | Least Squares Mean | 90% Confidence Interval | nanogram per millileter (ng/mL) | Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose |
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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 | Atomoxetine Oral Solution | Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Japan |
| NOT COMPLETED |
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Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| weight (kg) | Mean | Standard Deviation | kilograms (kg) |
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| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tlast)] | The AUC (0-tlast) is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (tlast) and is based on the atomoxetine plasma concentration. The Least Squares (LS) Mean Value was based on treatment, period, group, and subject. | All participants who had an AUC value were included in the AUC analysis. | Posted | Least Squares Mean | 90% Confidence Interval | nanogram hour per milliliter (ng*h/mL) | Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 4, 6, 8, 12, 18, and 24 hours post dose |
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| 0 |
| 42 |
| 9 |
| 42 |
| EG001 | Atomoxetine Capsule Formulation | Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. | 0 | 40 | 6 | 40 |
| Blood pressure increased | Investigations | MedDRA 13.0 | Systematic Assessment |
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