Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product

Launched by LABORATORIOS ANDROMACO S.A. · Apr 11, 2022

Keywords

ClinConnect Summary

The primary objective of the study is to investigate the relative bioavailability of Estradiol Valerate and Dienogest 2mg/ 2mg of 1 tablet formulations with Estradiol Valerate and Dienogest 2mg/ 2mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

* Test Product: Product manufactured by Laboratorios Andromaco S.A.
* Reference Product: Climodien \[Trademark\], product Bayer plc. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the pla...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy post-menopausal female literate volunteers of 40 to 65 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight \> 50 Kg.
• • 2. Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
• • 3. Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
• • 4. Normal or clinically insignificant ECG.
• • 5. Negative urine test for drugs of abuse and negative pregnancy test.
• • 6. Volunteers who are willing to use acceptable methods of contraception (barrier method/IUD/surgical) or abstinence, for the entire duration of the study and do not plan to be pregnant for at least 1 month after the last drug administration.
• • 7. Volunteers who can give written informed consent and communicate effectively.
• Exclusion Criteria:
• • 1. History of any major surgical procedure in the past 03 months.
• • 2. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
• • 3. History of chronic alcoholism/ chronic smoking/ drug of abuse.
• • 4. Volunteers with known hypersensitivity to Dienogest/Estradiol Valerate or any of the excipients.
• • 5. History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing.
• • 6. Volunteers who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
• • 7. Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Dienogest/Estradiol Valerate or any other medication judged to be clinically significant by the investigator.
• • 8. History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
• • 9. Volunteers who had participated in any other clinical study or who had bled during the last 03 months before check-in.
• • 10. History of consumption of one or more of the below, 48 hours prior to dosing: Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator.
• • 11. Volunteers who are dysphagic.