Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product

• Status: Completed
• Trial end date: 2020-11-17
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Andromaco S.A.
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Levonorgestrel; Polyestradiol phosphate

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 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