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The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eszopiclone 3 mg tablet | Experimental |
| |
| Eszopiclone 1 mg tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eszopiclone 3 mg | Drug | Group A Period I, Group B Period II: Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting >=10 hours. Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration of drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of drug. Group B Period III: Eszopiclone 3 mg tablet taken po with water as a single administration in the morning 30 minutes after the start of breakfast. Except for the food/ drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink from 10 hours before until 4 hours after administration of the drug. Except for the food/ drink at breakfast & the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax) | Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). | immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
| Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24]) | Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). | immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
| Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax) | Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). | immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
| Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24]) | Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). |
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Inclusion criteria;
Exclusion criteria;
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| Name | Affiliation | Role |
|---|---|---|
| Kenya Nakai | Japan Clinical Pharmacology, Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida City | Tokyo | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs | Participants received a single dose of Eszopiclone one 3 mg tablet administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in Period II. At least a 5 day period passed before post treatment examinations. |
| FG001 | Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab | Participants received a single dose of Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone one 3 mg tablet with water in the morning after fasting for 10 or more hours in Period II. After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period I |
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| Treatment Period II |
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| Treatment Period III |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs | Participants received Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. At least a 5 day period passed before post treatment examinations. |
| 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 | Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax) | Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to confirm bioequivalence. Cmax was measured in nanograms per milliliter (ng/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). | Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1. | Posted | Mean | Standard Deviation | ng/mL | immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
|
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Safety Analysis Set (bioequivalence): population treated in Period I except for those subjects with no available safety data.
Safety analysis set (food effect): is defined as the "safety analysis set (bioequivalence)" except for those subjects with no evaluable safety data in Period III.
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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 | Eszopiclone One 3 mg Tablet | Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA (13.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenya Nakai, Study Director | Eisai Co., Ltd. | +81-3-3817-3865 | k3-nakai@hhc.eisai.co.jp |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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|
| Eszopiclone 1 mg | Drug | Group A Period II, Group B Period I: Eszopiclone three 1 mg tablets (total: 3 mg) taken orally with water as a single administration in the morning after fasting 10 or more hours. Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug. |
|
| immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab | Participants received Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone one 3 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. After Period II there was at least a 5 day washout period. Certain participants from Group B only proceeded to Period III where they received Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast for 3 days. At least a 5 day period passed before post treatment examinations. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Eszopiclone Three 1 mg Tablets | Group A Period II, Group B Period I: Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours. Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug. |
|
|
| Primary | Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24]) | Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to confirm bioequivalence. AUC was measured in nanogram hours per milliliter (ng*h/mL). Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). | Pharmacokinetic analysis set (bioequivalence set): All participants who completed the study and had their samples analyzed, except for one participant in Group A who discontinued the study in Period 1. | Posted | Mean | Standard Deviation | ng*h/mL | immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
|
|
|
| Primary | Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax) | Pharmacokinetic parameter: maximal drug concentration (Cmax) was measured in order to investigate the effect of food. Cmax was measured in nanograms per milliliter (ng/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). | Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups. | Posted | Mean | Standard Deviation | ng/mL | immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
|
|
|
| Primary | Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24]) | Pharmacokinetic parameter: Area under the plasma concentration- time curve from time 0 (administration of the drug) to time 24 hours was measured in order to investigate the effect of food. AUC was measured in nanogram hours per milliliter (ng*h/mL) and was measured under fasted and fed conditions. Blood sampling was calculated immediately before administration of the study drug and 24 hours after administration of the study drug (0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose). | Pharmacokinetic analysis set (food effect): 14 participants who completed both Period II and Period III, who had been assigned to move on to Period III when assigned to treatment groups. | Posted | Mean | Standard Deviation | ng*hr/mL | immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose |
|
|
|
| 0 |
| 42 |
| 2 |
| 42 |
| EG001 | Eszopiclone Three 1 mg Tablets | Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II). | 0 | 41 | 4 | 41 |
| EG002 | Eszopiclone One 3 mg Tablet (Fed) | After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fed conditions. | 0 | 14 | 0 | 14 |
| EG003 | Eszopiclone One 3 mg Tablet (Fasted) | After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fasted conditions. | 0 | 14 | 1 | 14 |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.0) |
|
| Pyrexia | General disorders | MedDRA (13.0) |
|
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| D001523 |
| Mental Disorders |
| D011725 |
| Pyridines |