Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product

Launched by LABORATORIOS ANDROMACO S.A. · Jun 4, 2020

Keywords

ClinConnect Summary

The primary objective of the study is to investigate the relative bioavailability of Desogestrel of 2 tablet formulations with Desogestrel 0.075 mg to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:

* Test Product: Product manufactured by Laboratorios Andrómaco S.A.
* Reference Product: Cerazette \[Trademark\], product of Merck Sharp and Dohme Ltda., Brasil.

The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time cu...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Non-pregnant and non-breastfeeding women
• • Women of childbearing age with an acceptable form of contraception during the study
• • 18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or equal to 29.99
• • Non-smoking or smoke only 3 cigarettes every 7 days
• • With results of laboratory tests, electrocardiogram and chest radiography in normal and / or negative or abnormal ranges but without clinical relevance and declared suitable for study by the doctor after the physical examination
• • Capable to understand the Informed Consent Form
• Exclusion Criteria:
• • Study site staff or sponsor staff or family members
• • With history of drug and/or alcohol abuse
• • Smokers more tan 3 cigarettes every 7 days
• • Vitamin supplements intake 7 days prior to the administration of the medications under study
• • Any recent change in eating habits or physical exercise
• • Using of a pharmacological therapy (except over the counter medication use 7 days prior to the study)
• • Hypersensitivity to the study drug or to other chemically related compounds, history of serious adverse reactions or hypersensitivity to any medication
• • Use, during the 28 days prior to the start of the study, of medications known to alter liver enzyme activity
• • Consumption of beverages or food containing grapefruit or pink grapefruit, within 7 days prior to each administration of the study medication and consumption of alcohol, caffeine or beverages or foods containing xanthines 24 hours before each administration of the study medication until the last sample of each period
• • History of any significant cardiovascular disease
• • Acute disease that generates significant physiological changes from the time of selection until the end of the study
• • HIV, Hepatitis B and/or C positive
• • Presence or history of thrombophlebitis, thrombosis or thromboembolic disorders, deep vein thrombosis, pulmonary embolism or known coagulopathy.
• • Donation or loss of a significant volume (more than 100 mL) of blood or plasma or platelets during the 3 months prior to the start of the study
• • Subjects who have participated in any type of clinical study during the 3 months prior to the start of the study
• • History of any gastrointestinal surgery that could affect drug absorption
• • Presence of fainting history or fear to blood collection