Status:
COMPLETED
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
Lead Sponsor:
Laboratorios Andromaco S.A.
Conditions:
Therapeutic Equivalency
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief Summary
This study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The study will be performed at a single site with 36 ...
Detailed Description
The primary objective of the study is to investigate the relative bioavailability of Levonorgestrel and Ethinyl estradiol of 2 tablet formulations with Levonorgestrel 15.0 mg and Ethinyl estradiol 0.0...
Eligibility Criteria
Inclusion
- Healthy non-pregnant, non-breast feeding female literate volunteers of 18 to 45 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight \> 50 Kg.
- Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
- Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
- Normal or clinically insignificant EC.
- Negative urine test for drugs of abuse, negative pregnancy test and do not plan to become pregnant during course of the study and for 03 months after completion of study.
- 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.
- Volunteers who can give written informed consent and communicate effectively.
Exclusion
- History of any major surgical procedure in the past 03 months.
- History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
- History of chronic alcoholism/ chronic smoking/ drug of abuse.
- Volunteers with known hypersensitivity to Ethinyl-estradiol and Levonorgestrel or any of the excipients.
- History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
- Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
- 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 Ethinyl-estradiol and Levonorgestrel or any other medication judged to be clinically significant by the investigator.
- History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
- Volunteer who had participated in any other clinical study or who had bled during the last 03 months before check-in.
- 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.
- Volunteers who are dysphagic
Key Trial Info
Start Date :
February 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05282940
Start Date
February 26 2022
End Date
April 8 2022
Last Update
June 2 2022
Active Locations (1)
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1
Azidus Laboratories Ltd.
Chennai, Tamil Nadu, India, 600048