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Drug interactions
Applicant’s response: The in vitro and in-vivo results of (R)-zopiclone are sufficient in their view to demonstrate that Rzopliclone has indeed some pharmacological activity (in particular eszopiclone CNS depressant-like activity) and that this activity interferes with the pharmacological activity of (S)-zopiclone in the racemic mixture .
The comparative PK study 190-010 raised doubts about pharmaceutical comparison of the eszopiclone preparations used in this study .
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