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

NCT04230070 | Completed Phase 1

• 1 other identifier: HP8814-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

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 marketed reference 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 Reference Product

Interventions

Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug DRUG

Bioequivalence

Also known as: Investigational Medicinal Product

Levonorgestrel and Ethinyl estradiol Test Product

Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Product DRUG

Bioequivalence

Also known as: Microgynon CD (Trademark)

Levonorgestrel and Ethinyl estradiol Reference Product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-pregnant and non-breastfeeding women
• Women of childbearing age with an acceptable form of contraception during the study
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Andromaco S.A.: lead

Study Sites (1)

Innolab

Santiago, 7510491, Chile

Location

MeSH Terms

Interventions

Levonorgestrel; Ethinyl Estradiol; Drug Evaluation; Patents as Topic

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; Intellectual Property; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations

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: January 13, 2020
• First Posted: January 18, 2020
• Study Start: October 24, 2020
• Primary Completion: October 31, 2020
• Study Completion: November 17, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)