Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects

NCT05125640 | Completed Phase 1

• 1 other identifier: FK/BE/PROG/19
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics

Keywords

bioequivalence; pharmacokinetics; generic drugs; Progesterone; Soft Capsule; oral dosage form

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration

  up to 96 hours post-administration

• AUC0-last

  Area under the plasma concentration-time curve from 0 hours to the time of last quantified concentration

  up to 96 hours post-administration

Secondary Outcomes (5)

• Tmax.

  up to 96 hours post-administration

• AUC0→inf

  up to 96 hours post-administration

• Residual area (%).

  up to 96 hours post-administration

• λz

  up to 96 hours post-administration

• t1/2

  up to 96 hours post-administration

Study Arms (2)

Treatment A

EXPERIMENTAL

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

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

Treatment B

ACTIVE COMPARATOR

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

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

Interventions

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

Orally, with 240 mL of water at dosing in sitting position

Also known as: Injesta

Treatment A

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

Orally, with 240 mL of water at dosing in sitting position

Also known as: Utrogestan®

Treatment B

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Inclusion Criteria: \- Healthy postmenopausal females. Duration of menopause has to be more than 1 year on the day of informed consent.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smokers or past-smokers (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) between 18.5 and 30 kg/m2 inclusive, and body weight not less than 45 kg (on the day of screening).
• Subject is available for the whole study and has provided her written informed consent.
• Subject is in good health as determined by screening medical history, physical examination, vital signs assessment (pulse rate, systolic and diastolic blood pressure and body temperature) and 12-lead ECG.Minor deviations outside the reference ranges will be acceptable, if dement not clinically significant by the Investigator.
• Acceptance of use of contraceptive measures during the whole study.
• Caucasian race.
• Normal liver and kidney functions tests. (On Screening).
• Results of laboratory tests (Prothrombin time (PT) and activated partial thromboplastin time (APTT), Thrombin Time (TT) tests also Erythrocyte sedimentation rate (ESR) and Hormones (follicle-stimulating hormone (FSH), luteinizing hormone (LH), Estradiol, Progesterone and Prolactin hormone (PRL)) results are within normal range or being assessed as clinically non-significant by the attending physician.(On Screening)

You may not qualify if:

• Known cardiovascular disease or history of hypotension.
• History of gout, urolithiasis, nephrolithiasis and hyperuricemia.
• 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 kidney disease with impaired renal function.
• History of severe allergy or allergic reactions to the study IMP, its excipients or related drugs, wheat allergy history, allergy to soya and peanut in anamnesis.
• History of unexplained vaginal bleeding.
• Positive result of urine pregnancy test at screening or positive urine pregnancy test at check-in or breastfeeding or lack of results of pregnancy test.
• Benign neoplasms and anamnesis of hyperplastic processes including mastopathy.
• Arterial or venous thromboembolism or thrombophlebitis in anamnesis.
• Reporting drug of abuse at screening \& positive results of drug of abuse at check-in in each period.
• Positive result of alcohol breath test at check-in.
• The presence of nicotine or cotinine in urine on screening.
• Serious mental disease and/or inability to cooperate with clinical team.

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

Model Details: Comparative, Randomized, Two-Sequence, Two-Treatment, Four-Period, Open-Label, Single oral Dose, Fully Replicated, Crossover bioequivalence Study

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: December 13, 2019
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)