Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route

NCT05125627 | Completed Phase 1

• 1 other identifier: FK/BE/PGIV/19
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to assess the bioequivalence of Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) versus Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) after a single Vaginal dose in healthy female subjects under fasting conditions.

Conditions

Pharmacokinetics

Keywords

bioequivalence; pharmacokinetics; generic drugs; Progesterone; Soft Capsule

Outcome Measures

Primary Outcomes (2)

• Cmax

  Cmax - Maximum plasma concentration derived/calculated from the concentrations of Progesterone Corrected determined in individual plasma samples for each subject

  up to 72 hours post-administration

• AUC0→last

  AUC0→last -The area under the plasma concentration-time curve

  up to 72 hours post-administration

Secondary Outcomes (5)

• Tmax

  up to 72 hours post-administration

• AUC0→inf

  up to 72 hours post-administration

• λz

  up to 72 hours post-administration

• Residual area (%)

  up to 72 hours post-administration

• t1/2

  up to 72 hours post-administration

Study Arms (2)

Treatment A

EXPERIMENTAL

Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator

Drug: Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)

Treatment B

ACTIVE COMPARATOR

Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator

Drug: Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)

Interventions

Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) DRUG

Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator

Also known as: Injesta

Treatment A

Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) DRUG

Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator

Also known as: Utrogestan®

Treatment B

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: -Healthy postmenopausal females with amenorrhea duration of at least 6 months, but not more than 24 months.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smoker or past-smoker (an ex-smoker is defined as someone who has completely stopped using nicotine products, including nicotine cessation therapy, for at least 180 days prior to the first study drug administration).
• Body Mass Index (BMI) ≥18.5 and ≤ 30 kg/m2, inclusive and body weight between 45 kg and 100 kg(on the day of screening).
• Subject is available for the whole study and has provided her written informed consent
• Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (pulse rate, systolic and diastolic blood pressure, and body temperature) and 12-lead electrocardiogram (ECG) . Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the Investigator.
• Acceptance of use of contraceptive measures during the whole study.
• Normal Liver and kidney function tests (on Screening)
• All laboratory screening results within the normal range, or deemed clinically insignificant by Investigator.
• The thickness of the endothelial layer according to ultrasound of the pelvic organs is not less than 2 mm and not more than 4 mm (on Screening)

You may not qualify if:

• Known cardiovascular disease, history of hypotension
• History of gout, urolithiasis, nephrolithiasis and hyperuricaemia
• Gastrointestinal diseases, including gastric ulcer, renal or hepatic diseases and/or pathological findings present or in history, which might interfere with the drug pharmacokinetics.
• Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug's safety, tolerability, bioavailability and/or pharmacokinetics of the Investigational Medicinal Product (IMP).
• History of severe allergy or allergic reactions to the study IMP, its excipients or related drugs, wheat allergy history.
• Positive result of urine pregnancy test at screening or breast-feeding or lack of results of pregnancy test.
• Postponed acute diseases of the female genitals during the last 3 months, including vaginitis and / or vulvovaginitis.
• Chronic inflammatory and/or atrophic diseases of the pelvic organs.
• Benign neoplasms and anamnesis of hyperplastic processes, including mastopathy and endometrial hyperplasia.
• Surgical intervention on the pelvic organs, including hysterectomy, adnexectomy (It doesn't include the Subject who had a previous history of Cesarean section for 5 years or more provided that the Cesarean section was not for pathological reasons and/ or accompanied with cervix and uterus diseases or external genitals organs disease).
• Arterial or venous thromboembolism or thrombophlebitis in anamnesis.
• Reporting drug of abuse at screening
• Positive result of alcohol breath test at screening.
• The presence of nicotine or cotinine in urine at the screening.

Sponsors & Collaborators

• Joint Stock Company "Farmak": lead

Study Sites (1)

Arab Pharmaceutical Industry Consulting/Pharmaceutical Research Unit

Amman, 11910, Jordan

Location

MeSH Terms

Interventions

Progesterone; Utrogestan

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Vlad Udovytskyi

  Joint Stock Company "Farmak"

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: August 28, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)