Bioequivalence Clinical Trial
Official title:
Bioavailability of a Formulation of Levonorgestrel and Ethinyl Estradiol 15.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product
Verified date | January 2021 |
Source | Laboratorios Andromaco S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Pivotal study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal study will be performed at a single site with 30 subjects. Participants will take 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 17, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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 or sponsor staff or any of their 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 |
Country | Name | City | State |
---|---|---|---|
Chile | Innolab | Santiago |
Lead Sponsor | Collaborator |
---|---|
Laboratorios Andromaco S.A. |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) | 19 samples up to 72 hours will be taken after the administration in each period. | From tablet intake and up to 72 hours after tablet intake | |
Primary | Total Levonorgestrel: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72) | 19 samples up to 72 hours will be taken after the administration in each period | From tablet intake and up to 72 hours after tablet intake | |
Primary | Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to time t (AUC0-t) | 19 samples up to 72 hours will be taken after the administration in each period | From tablet intake and up to 72 hours after tablet intake | |
Primary | Total Levonorgestrel: area under the plasma concentration-time curve from 0 to time t (AUC0-t) | 19 samples up to 72 hours will be taken after the administration in each period | From tablet intake and up to 72 hours after tablet intake | |
Primary | Total Ethinyl estradiol: Maximum plasma concentration (Cmax) | 19 samples up to 72 hours will be taken after the administration in each period | From tablet intake and up to 72 hours after tablet intake | |
Primary | Total Levonorgestrel: Maximum plasma concentration (Cmax) | 19 samples up to 72 hours will be taken after the administration in each period | From tablet intake and up to 72 hours after tablet intake | |
Primary | Total Levonorgestrel: Time to achieve maximum plasma concentration (tmax) | 19 samples up to 72 hours will be taken after the administration in each period | From tablet intake and up to 72 hours after tablet intake | |
Primary | Total Ethinyl estradiol: Time to achieve maximum plasma concentration (tmax) | 19 samples up to 72 hours will be taken after the administration in each period | From tablet intake and up to 72 hours after tablet intake |
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