Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product

NCT04193852 | Completed Phase 1

• 1 other identifier: HP8811-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg. The Pilot study will be performed at a single site with 10 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) ]

  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 Dienogest: 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: area under the plasma concentration-time curve from 0 to time t (AUC0-t)

  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 Dienogest: area under the plasma concentration-time curve from 0 to time t (AUC0-t)

  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 dienogest: 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 dienogest: 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 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

Study Arms (2)

Dienogest and Ethinyl estradiol Test Product

EXPERIMENTAL

Participants will receive two tablets of the test formulation containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water and in a fasting condition.

Drug: Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug

Dienogest and Ethinyl estradiol Reference Product

ACTIVE COMPARATOR

Participants will receive two tablets of the marketed reference formulation containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water and in a fasting condition.

Drug: Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Reference Product

Interventions

Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug DRUG

Coated Tablets

Also known as: Investigational Medicinal Product

Dienogest and Ethinyl estradiol Test Product

Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Reference Product DRUG

Coated Tablets

Also known as: Valette (Trademark)

Dienogest 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 staff or 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

dienogest; Ethinyl Estradiol; Drug Evaluation; Patents as Topic

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 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 Officials

• Study Director Laboratorios Andromaco

  Grünenthal Group

  STUDY DIRECTOR

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: November 8, 2019
• First Posted: December 10, 2019
• Study Start: November 9, 2019
• Primary Completion: November 12, 2019
• Study Completion: November 25, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)