Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product

NCT04713904 | Completed Phase 1

• 1 other identifier: HP8822-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be performed at a single site with 38 subjects. Participantswill 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 (6)

• Total Clormadinone: 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.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

• 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.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

• Total Clormadinone: 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.

  [Time Frame: 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.

  [Time Frame: 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. The Cmax will be calculated.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

• Total Clormadinone: Maximum plasma concentration (Cmax) 21 samples up to 72 hours will be taken after the administration in each period. The Cmax will be calculated.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

Secondary Outcomes (2)

• Total Clormadinone: Time to achieve maximum plasma concentration (tmax) 21 samples up to 72 hours will be taken after the administration in each period. The tmax will be calculated.

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

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

  [Time Frame: From tablet intake and up to 72 hours after tablet intake]

Study Arms (2)

Clormadinone Ethinyl estradiol Test Product

EXPERIMENTAL

Drug: Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Test Product Coated Tablets

Clormadinone Ethinyl estradiol Reference Product

ACTIVE COMPARATOR

Drug: Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Reference Product Coated Tablets

Interventions

Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Test Product Coated Tablets DRUG

Investigational Medicinal Product

Clormadinone Ethinyl estradiol Test Product

Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Reference Product Coated Tablets DRUG

Evafem 20 (Trademark)

Clormadinone 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 pharmacological therapy (except over the counter medication use 7 days prior the study)
• Hypersensitivity to the study drug or other related compounds, history of serious adverse reactions or hypersensitivity to any medication
• Use, during 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 food containing xanthine 24 hours prior each administration of study medication until the last sample of each period
• History of any significant cardiovascular disease
• Acute disease that generates significant physiological changes from the start of the selection until the end of the study
• HIV, Hepatitis B and/or C positive
• Presence or history of thrombophlebitis, thrombosis or thromboembolic disorder, deep vein thrombosis, pulmonary embolism or known coagulopathy.
• Donation or loss of a significant volume (more tan 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

Ethinyl Estradiol

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

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 14, 2021
• First Posted: January 19, 2021
• Study Start: January 16, 2021
• Primary Completion: January 16, 2021
• Study Completion: February 2, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)