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A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)

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ClinicalTrials.gov Identifier: NCT01055834
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : February 12, 2013
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Insomnia
Interventions: Drug: Eszopiclone 3 mg
Drug: Eszopiclone 1 mg

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.


Participant Flow for 3 periods

Period 1:   Treatment Period I
    Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs   Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab
STARTED   21   21 
COMPLETED   20   21 
NOT COMPLETED   1   0 
Adverse Event                1                0 

Period 2:   Treatment Period II
    Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs   Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab
STARTED   20   21 
COMPLETED   20   21 
NOT COMPLETED   0   0 

Period 3:   Treatment Period III
    Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs   Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab
STARTED   0 [1]   14 [2] 
COMPLETED   0   14 
NOT COMPLETED   0   0 
[1] Participants from Group A did not continue into Period III.
[2] 14 of 21 participants in Group B who were treated in Period II participated in Period III.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.

Total Total of all reporting groups

Baseline Measures
   Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs   Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   21   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.3  (6.0)   33.0  (9.4)   31.2  (8.0) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   20   21   41 


  Outcome Measures

1.  Primary:   Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax)   [ Time Frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose ]

2.  Primary:   Pharmacokinetic Parameter (Bioequivalence): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])   [ Time Frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose ]

3.  Primary:   Pharmacokinetic Parameter (Food Effect): Maximal Drug Concentration (Cmax)   [ Time Frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose ]

4.  Primary:   Pharmacokinetic Parameter (Food Effect): Area Under the Plasma Concentration- Time Curve From Time 0 to Time 24 Hours (AUC[0-24])   [ Time Frame: immediately before administration & 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kenya Nakai, Study Director
Organization: Eisai Co., Ltd.
phone: +81-3-3817-3865
e-mail: k3-nakai@hhc.eisai.co.jp



Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01055834     History of Changes
Other Study ID Numbers: 190-102
First Submitted: January 25, 2010
First Posted: January 26, 2010
Results First Submitted: January 10, 2013
Results First Posted: February 12, 2013
Last Update Posted: February 12, 2013