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

NCT05282940 | Completed Phase 1

• 1 other identifier: HP8814-03
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Therapeutic Equivalency

Outcome Measures

Primary Outcomes (6)

• Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)

  21 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

• Total Levonorgestrel: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)

  21 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

• Total Ethinyl estradiol: Maximum plasma concentration (Cmax)

  21 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

• Total Levonorgestrel: Maximum plasma concentration (Cmax)

  21 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

• Total Ethinyl estradiol: Time to achieve maximum plasma concentration (tmax)

  21 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

• Total Levonorgestrel: Time to achieve maximum plasma concentration (tmax)

  21 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

Study Arms (2)

Levonorgestrel and Ethinyl estradiol Test Product

EXPERIMENTAL

Participants will receive two tablets of the test formulation containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water.

Drug: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug

Levonorgestrel and Ethinyl estradiol Reference Product

ACTIVE COMPARATOR

Participants will receive two tablets of the test marketed reference formulation containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water.

Drug: Microgynon CD

Interventions

Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug DRUG

Investigational Medicinal Product

Levonorgestrel and Ethinyl estradiol Test Product

Microgynon CD DRUG

Microgynon CD will be used as a comparator drug for the BE study. Other Name: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Drug

Levonorgestrel and Ethinyl estradiol Reference Product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Azidus Laboratories Ltd.

Chennai, Tamil Nadu, 600048, India

Location

MeSH Terms

Interventions

Levonorgestrel; Ethinyl Estradiol; Drug Evaluation

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norpregnatrienes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 16, 2022
• Study Start: February 26, 2022
• Primary Completion: March 15, 2022
• Study Completion: April 8, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)