Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product

NCT05332106 | Completed Phase 1

• 1 other identifier: HP8833-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg. The study will be performed at a single site with 10 subjects. Participants will take 1 tablet 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 7 days between each study period.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (6)

• Total Estradiol Valerate: area under the plasma concentration-time curve from 0 to time t (AUC0-72)

  26 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 Estradiol Valerate: Maximum plasma concentration (Cmax)

  26 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 Estradiol Valerate: Time to achieve maximum plasma concentration (tmax)

  26 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 (AUC0-72)

  26 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)

  26 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)

  26 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)

Estradiol Valerate and Dienogest Test Product.

EXPERIMENTAL

Participants will receive one tablet of the test formulation containing Estradiol Valerate and Dienogest 2 mg/ 2 mg.The tablet will be taken with water and in a fasting condition.

Drug: Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet

Estradiol Valerate and Dienogest Referent Product

ACTIVE COMPARATOR

Participants will receive one tablet of the marketed reference containing Estradiol Valerate and Dienogest 2 mg/ 2 mg. The tablet will be taken with water and in a fasting condition.

Drug: Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet

Interventions

Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet DRUG

Investigational Medicinal Product

Estradiol Valerate and Dienogest Test Product.

Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet DRUG

Climodien (Bayer plc.)

Estradiol Valerate and Dienogest Referent Product

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy post-menopausal female literate volunteers of 40 to 65 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 ECG.
• Negative urine test for drugs of abuse and negative pregnancy test.
• 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 Dienogest/Estradiol Valerate or any of the excipients.
• History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing.
• Volunteers 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 Dienogest/Estradiol Valerate 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.
• Volunteers 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

Estradiol; dienogest; Drug Evaluation

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• R. Amirtha, MD

  Azidus Laboratories Ltd.

  PRINCIPAL INVESTIGATOR

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: April 5, 2022
• First Posted: April 18, 2022
• Study Start: March 12, 2022
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)