PharmacokineticsPhase 1NCT05125640
Fasting Bioequivalence Study of 2 Oral Progesterone Soft Capsules 200 mg in 48 Healthy Female Subjects
A Phase 1 study testing Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) and Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) in people with Pharmacokinetics, run by Joint Stock Company "Farmak" at 1 site in Jordan.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) and Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteJordan
- Study dates
- 13 Dec 2019to 7 Jan 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 37Show fewer
- 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.
- Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic BP and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm during the screening procedure.
- Body temperature is out of the range of 35.7-37.6°C at screening.
- Orthostatic hypotension during screening procedure or in the history.
- Reporting drugs or alcohol (of≥ 40 g per day pure ethanol), solvents or caffeine abuse at screening and check-in in each period.
- Donation of at least 400 ml of blood within 60 days, more than 150 ml of blood within 30 days or more than 100 ml blood plasma or platelets within 14 days before study Period I.
- Following a special diet (e.g. vegetarian) or dieting one month before the study initiation
- Less than 80 days between exit procedure in previous study and the first dosing in this study.
- Any significant clinical abnormality including Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), and / or (human immunodeficiency virus) HIV. (On screening)
- Abnormal kidney and/or liver function tests and being assessed as clinically significant by the attending physician.(On Screening).
- Results of laboratory tests( including PT and APTT, TT tests also Erythrocyte sedimentation rate (ESR) and Hormones (FSH, LH, Estradiol, Progesterone and Prolactin hormone (PRL) are outside the normal range and being assessed as clinically significant by the attending physician.
- Uric acid level for women > 6.0 mg/dL on screening.
- Previous liver disease or elevations in serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.0 upper limit of normal (ULN) at the screening (ALT for women up to 63 U/L and AST up to 37 U/L).
- The intake of caffeine, xanthenes, or carbon dioxide CO2-containing beverages within 18 hours of drug administration.
- Consumption of alcohol, grapefruit or grapefruit containing products within 7 days of drug administration
- Ingestion of any supplements like vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Clinically significant illness within 28 days before the first dosing, including major surgery.
- Exhausting physical exercise in the last 48 hours (e.g. weight lifting) or any recent significant change in dietary or exercise habits.
- Abnormal Vital Signs and being assessed as clinically significant by the attending physician.
- Vomiting or diarrhea on admission.
- Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 80 days before the first dosing.
- Use of any prescription medication for a period of 14 days before the first dosing.
- Any systemic over-the-counter (OTC) drug treatment and/or vitamins and/or herbal treatment and/or food supplements within 14 days before the first dosing.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Arab Pharmaceutical Industry Consulting/Pharmaceutical Research Unit
Amman, 11910
About this study
Official title: Randomized, Two-Sequence, Two-Treatment, Four-Period, Open-Label, Single Oral Dose, Crossover Bioequivalence Study of Progesterone 200 mg Soft Capsule vs Utrogestan® in Healthy Female Subjects Under Fasting Conditions
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
Read the detailed description
An open-label, randomized, single dose, two-treatment, four-period, two-sequence, fully replicated crossover bioequivalence study with a washout period of 7 days in healthy postmenopausal female subjects under fasting conditions.
During each period 26 blood samples were drawn 5 mL at (-1.00, -0.50, -0.137) before dosing and at 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 hours after dosing.
Mode of administration: Orally, with 240 mL of water at dosing in sitting position
Bioequivalence Acceptance Criteria:
▲Cmax (Maximum plasma concentration): Scaled average bioequivalence will be performed. Bioequivalence limits will be defined and widened according to the variance of σw2 within subject variability for the reference based on corrected progesterone.
AUC0-last (the area under the plasma concentration-time curve): The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on corrected Progesterone.
▲Based on Cmax CVR% (Coefficient of Variation Ratio )=50.97% the calculated confidence interval acceptance limits were (69.83%-143.19%)
- Conditions
- Pharmacokinetics
- Being tested
- Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine), Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)
- Keywords
- bioequivalence, pharmacokinetics, generic drugs, Progesterone, Soft Capsule, oral dosage form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)Drug
Also called Injesta
Orally, with 240 mL of water at dosing in sitting position
Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)Drug
Also called Utrogestan®
Orally, with 240 mL of water at dosing in sitting position
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) Receives: 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) Receives: Drug: Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 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
Measured: up to 96 hours post-administration
Secondary outcomes (5)
Tmax.
Time point of maximum plasma concentration
Measured: up to 96 hours post-administration
AUC0→inf
Area under the plasma concentration-time curve from 0 hours to infinity
Measured: up to 96 hours post-administration
Residual area (%).
Residual area (%).
Measured: up to 96 hours post-administration
λz
Terminal elimination rate constant
Measured: up to 96 hours post-administration
t1/2
Half-life of drug elimination during the terminal phase
Measured: up to 96 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start13 Dec 2019
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Comparative, Randomized, Two-Sequence, Two-Treatment, Four-Period, Open-Label, Single oral Dose, Fully Replicated, Crossover bioequivalence Study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Stock Company "Farmak"
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vlad Udovytskyi, Study chair, Joint Stock Company "Farmak"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125640
- Sponsor's protocol ID
- FK/BE/PROG/19
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Two-Sequence, Two-Treatment, Four-Period, Open-Label, Single Oral Dose, Crossover Bioequivalence Study of Progesterone 200 mg Soft Capsule vs Utrogestan® in Healthy Female Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05125640
- Acronym / sponsor ID
- FK/BE/PROG/19
- Conditions
- Pharmacokinetics
- Keywords
- bioequivalence, pharmacokinetics, generic drugs, Progesterone, Soft Capsule, oral dosage form
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Joint Stock Company "Farmak"Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
An open-label, randomized, single dose, two-treatment, four-period, two-sequence, fully replicated crossover bioequivalence study with a washout period of 7 days in healthy postmenopausal female subjects under fasting conditions.
During each period 26 blood samples were drawn 5 mL at (-1.00, -0.50, -0.137) before dosing and at 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00 and 96.00 hours after dosing.
Mode of administration: Orally, with 240 mL of water at dosing in sitting position
Bioequivalence Acceptance Criteria:
▲Cmax (Maximum plasma concentration): Scaled average bioequivalence will be performed. Bioequivalence limits will be defined and widened according to the variance of σw2 within subject variability for the reference based on corrected progesterone.
AUC0-last (the area under the plasma concentration-time curve): The 90% confidence interval for this measure lies within an acceptance range of 80.00% - 125.00% based on corrected Progesterone.
▲Based on Cmax CVR% (Coefficient of Variation Ratio )=50.97% the calculated confidence interval acceptance limits were (69.83%-143.19%)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative, Randomized, Two-Sequence, Two-Treatment, Four-Period, Open-Label, Single oral Dose, Fully Replicated, Crossover bioequivalence Study
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) |
| Treatment B | Active comparator | Drug: Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (37 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)Also: InjestaOrally, with 240 mL of water at dosing in sitting position | Drug | Treatment A |
| Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)Also: Utrogestan®Orally, with 240 mL of water at dosing in sitting position | Drug | Treatment B |
Primary outcome
Cmax
Time frame: up to 96 hours post-administration
Maximum plasma concentration
AUC0-last
Time frame: up to 96 hours post-administration
Area under the plasma concentration-time curve from 0 hours to the time of last quantified concentration
5 secondary outcomes
Tmax.
Time frame: up to 96 hours post-administration
AUC0→inf
Time frame: up to 96 hours post-administration
Residual area (%).
Time frame: up to 96 hours post-administration
λz
Time frame: up to 96 hours post-administration
t1/2
Time frame: up to 96 hours post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vlad Udovytskyi study chair
Joint Stock Company "Farmak"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) and Utrogestan® 200 mg Soft Capsule (Manufacturer by: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France) in people with Pharmacokinetics, run by Joint Stock Company "Farmak" at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: up to 96 hours post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.