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About
The objective of this study is to assess the bioequivalence of the test product, Exemestane 25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin® (exemestane) 25 mg tablets of Pharmacia & Upjohn Company, Division of Pfizer Inc., New York, United States of America in healthy male and postmenopausal female subjects, under fasting conditions
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Inclusion criteria
Healthy male subjects, 18 to 55 years of age and postmenopausal female subjects, 18 years to not older than 75 years of age (inclusive at time of screening).
Body Mass Index (BMI) between 19 and 33 kg/m2 (relates to a body mass within 15% of ideal body mass for height and age).
Body mass not less than 50 kg.
Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
Non-smoker or mild to moderate smoker (≤ 10 cigarettes daily).
Females, if:
Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased, but if not increasing upon repeat, the female will be included in the study.
• Not on thyroid hormone replacement therapy or on stable thyroid hormone replacement therapy for at least 3 months before the first administration of IMP.
Not on statin therapy or on stable statin therapy for at least 3 months before the first administration of IMP.
• Blood pressure measurements are within the acceptable ranges; or, if diagnosed with hypertension, are on stable therapy for at least 3 months before the first administration of IMP.
Note: Treatment with calcium channel blockers is NOT allowed.
Written consent given for participation in the study. -
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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