Overview

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

Status:
Recruiting
Trial end date:
2022-03-15
Target enrollment:
0
Participant gender:
Female
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 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
Ethinyl Estradiol
Ethinyl Estradiol-Norgestrel Combination
Ethinyl estradiol, levonorgestrel drug combination
Levonorgestrel
Criteria
Inclusion Criteria:

1. 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.

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 EC.

5. 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.

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 Ethinyl-estradiol and Levonorgestrel or any
of the excipients.

5. History of consumption of tobacco containing products within 48 hours prior to
proposed time of dosing

6. Volunteer 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
Ethinyl-estradiol and Levonorgestrel 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. Volunteer 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