PharmacokineticsPhase 1NCT05125627
Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route
A Phase 1 study testing Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine) and Utrogestan® 200 mg Soft Capsule (Manufacturer: 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 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… 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: 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
- 66 participants
- Where
- 1 siteJordan
- Study dates
- 28 Aug 2019to 21 Oct 2019
- 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-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)
Who cannot join
- 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.
Show all 47Show fewer
- 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.
- 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 the screening procedure or in the history.
- Reporting Drug, alcohol (of ≥ 40 g per day pure ethanol), solvents or caffeine abuse at screening.
- Getting a tattoo, body piercing or any cosmetic treatment involving skin piercing within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study.
- Donation of at least 400 ml of blood within 60 days, or 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
- Allergy on peanut in anamnesis
- 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 are outside the normal range and being assessed as clinically significant by the attending physician (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).
- Any significant clinical abnormality, including a positive result of HBsAg and/or HCV and/or HIV test during screening procedure.
- Uric acid level for women > 6.0 mg/dl at the screening
- History of kidney disease with impaired renal function and level of creatinine in blood out of the normal laboratory range based on screening
- Anemia, hemoglobin below 12.0 g/L at screening.
- 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.
- 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, Diarrhea on admission.
- Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism within 90 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.
- Clinically significant illness within 28 days before the first dosing, including major surgery.
- Positive results of drug of abuse at check-in.
- Positive result of alcohol breath test at check-in.
- Reporting Drug, alcohol (of ≥ 40 g per day pure ethanol), solvents or caffeine abuse at check-in
- Positive urine pregnancy test at check-in.
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 Dose, Crossover, Intravaginal Bioequivalence Study of 200 mg Soft Capsule Progesterone vs Utrogestan® in Healthy Female Subjects Under Fasting Conditions.
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.
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 female subjects under fasting conditions.Mode of administration:Intravaginally, the capsule introduced deeply into the vagina while lying down.During each period 25 blood samples were drawn 5 mL at (-1.00,-0.50,-0.137), before dosing and at 0.50, 1.00, 1.50, 2.00,2.50, 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, 24.00,36.00, 48.00, and 72.00 hours after dosing.
- Conditions
- Pharmacokinetics
- Being tested
- Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine), Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)
- Keywords
- bioequivalence, pharmacokinetics, generic drugs, Progesterone, Soft Capsule
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
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
Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)Drug
Also called Utrogestan®
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Utrogestan® 200 mg Soft Capsule (Manufacturer: 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
Cmax - Maximum plasma concentration derived/calculated from the concentrations of Progesterone Corrected determined in individual plasma samples for each subject
Measured: up to 72 hours post-administration
AUC0→last
AUC0→last -The area under the plasma concentration-time curve
Measured: up to 72 hours post-administration
Secondary outcomes (5)
Tmax
Tmax -The time of the peak concentration
Measured: up to 72 hours post-administration
AUC0→inf
Area under the plasma concentration-time curve from 0 h to infinity
Measured: up to 72 hours post-administration
λz
λz-Terminal elimination rate constant
Measured: up to 72 hours post-administration
Residual area (%)
The residual areas were determined in % by the following equation: {(AUC0→inf - AUC0→last) /AUC0→inf}* 100. The unit is %.
Measured: up to 72 hours post-administration
t1/2
t1/2 -The terminal half-life
Measured: up to 72 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 start28 Aug 2019
- Primary completion21 Oct 2019
- Study completion21 Oct 2019
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
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT05125627
- Sponsor's protocol ID
- FK/BE/PGIV/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 Dose, Crossover, Intravaginal Bioequivalence Study of 200 mg Soft Capsule Progesterone vs Utrogestan® in Healthy Female Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT05125627
- Acronym / sponsor ID
- FK/BE/PGIV/19
- Conditions
- Pharmacokinetics
- Keywords
- bioequivalence, pharmacokinetics, generic drugs, Progesterone, Soft Capsule
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Joint Stock Company "Farmak"Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (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 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.
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 female subjects under fasting conditions.Mode of administration:Intravaginally, the capsule introduced deeply into the vagina while lying down.During each period 25 blood samples were drawn 5 mL at (-1.00,-0.50,-0.137), before dosing and at 0.50, 1.00, 1.50, 2.00,2.50, 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, 24.00,36.00, 48.00, and 72.00 hours after dosing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine)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 |
| Treatment B | Active comparator | Drug: Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)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 |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (47 listed)
- 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).
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: InjestaEach 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 | Treatment A |
| Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)Also: Utrogestan®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 | Treatment B |
Primary outcome
Cmax
Time frame: up to 72 hours post-administration
Cmax - Maximum plasma concentration derived/calculated from the concentrations of Progesterone Corrected determined in individual plasma samples for each subject
AUC0→last
Time frame: up to 72 hours post-administration
AUC0→last -The area under the plasma concentration-time curve
5 secondary outcomes
Tmax
Time frame: up to 72 hours post-administration
AUC0→inf
Time frame: up to 72 hours post-administration
λz
Time frame: up to 72 hours post-administration
Residual area (%)
Time frame: up to 72 hours post-administration
t1/2
Time frame: up to 72 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: 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 47 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 72 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.