Bioavailability of Eszopiclone 3.0 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the bioavailability in fasting healthy, adult, human subjects of
      1 tablet of two formulations containing Eszopiclone 3mg.

      The study will be performed at a single site with 28 subjects. Participants will take 1
      tablet of the test product 1, and 1 tablet of the test product 2, and reference product in 4
      periods and 2 sequences (either test after reference or reference after test). There will be
      a washout of at least 2 days between each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Eszopiclone 3mg of 1 tablet of 2 formulations with Eszopiclone 3mg and to demonstrate
      bioequivalence of the three formulations in terms of rate and extent of absorption:

        -  Test Product T-1: Product manufactured by Laboratorios Silesia S.A.

        -  Test Product T-2: Product manufactured by Laboratorios Andromaco S.A.

        -  Reference Product: Lunesta [Trademark], product of Sunovion Pharmaceuticals Inc. The 90%
           confidence intervals for the intra-subject coefficient of variation (Test products T1/T2
           versus Reference Product) for the main pharmacokinetic parameters area under the plasma
           concentration-time curve from time zero to time t (AUC0-t), and maximum plasma
           concentration (Cmax) for total Eszopiclone will be determined.

      Participants will be confined in the study site for approximately 9 days during the entire
      study (for 10 hours pre-dosing and for 24 hours post dosing after period IV) during which
      pharmacokinetic (PK) blood samples will be obtained. 24 blood samples will be taken up to 24
      hours after the administration in each period. The washout period between the four study
      periods will be at least 2 days. The samples from each participant will be analyzed with
      validated LC-MS/MS method for estimation of Eszopiclone in plasma. The safety objective is to
      evaluate the tolerability of both formulations in subjects by collecting adverse events.
    

Intervention name(s): Eszopiclone 3mg Test Drug T-1 Coated Tablets; Eszopiclone 3mg Test Drug T-2 Coated Tablets; Eszopiclone 3mg Reference Product Coated Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive one tablet of the test formulation T-1 containing Eszopiclone 3mg. The tablet will be taken with water and in a fasting condition.; Participants will receive one tablet of the test formulation T-2 containing Eszopiclone 3mg. The tablet will be taken with water and in a fasting condition.; Participants will receive one tablet of the Rerefence Product containing Eszopiclone 3mg. The tablet will be taken with water and in a fasting condition.
Other intervention name(s): Investigational Medicinal Product 1; Investigational Medicinal Product 2; Lunesta (Trademark)
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science