Assessment report

Test and reference products
Certificates of analysis of the test and reference product were provided by the applicant. The batch size
of the test product (190 000 Units) was considered acceptable by the CHMP.
The applicant confirmed that the composition and manufacturing process of the test product
formulation used in the bio-equivalence study and the formulation proposed for commercial supplies to
the European Economic Area is the same.
The CHMP noted, that the location of Certificate of Analysis given by the applicant in the table above
was incorrect and should be revised.
Population(s) studied
The study was conducted in Asian male population. The 60 subjects (male) who participated in this
study were healthy, in the age range of 45 to 60 years (mean age 50 years), a weight range of 45.6 to
84.2 kg (mean weight 61.1 kg), a height range of 146.0 to 180.0 cm (mean height 163.9 cm) and
Body Mass Index (BMI) range of 18.7 to 29.3 kg/m2 (mean BMI 22.7 kg/m 2 ).
A total of 47 healthy, adult, human subjects in Group-I and 31 in Group-II meeting the inclusion and
exclusion criteria as mentioned in the protocol were enrolled in to the study to ensure the dosing of
60 subjects.
Assessment report
EMA/49072/2016 Page 16/37