BioequivalencePhase 1NCT05332106
Bioavailability of Estradiol Valerate and Dienogest 2 mg/2 mg With Regards to Reference Product
A Phase 1 study testing Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet and Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet in people with Bioequivalence, run by Laboratorios Andromaco S.A. at 1 site in India.
Trial summary
This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg. The study will be performed at a single site with 10 subjects. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet and Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 12 Mar 2022to 22 Mar 2022
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy post-menopausal female literate volunteers of 40 to 65 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight > 50 Kg.
- Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
- Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
- Normal or clinically insignificant ECG.
- Negative urine test for drugs of abuse and negative pregnancy test.
- Volunteers who are willing to use acceptable methods of contraception (barrier method/IUD/surgical) or abstinence, for the entire duration of the study and do not plan to be pregnant for at least 1 month after the last drug administration.
- Volunteers who can give written informed consent and communicate effectively.
Who cannot join
- History of any major surgical procedure in the past 03 months.
- History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
- History of chronic alcoholism/ chronic smoking/ drug of abuse.
- Volunteers with known hypersensitivity to Dienogest/Estradiol Valerate or any of the excipients.
- History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing.
- Volunteers who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
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- Present or past history of intake of drugs or any prescription drug or over the counter (OTC) drugs within 14 days which potentially modify kinetics / dynamics of Dienogest/Estradiol Valerate or any other medication judged to be clinically significant by the investigator.
- History of consumption of grapefruit and/or its products within 10 days prior to the start of study.
- Volunteers who had participated in any other clinical study or who had bled during the last 03 months before check-in.
- History of consumption of one or more of the below, 48 hours prior to dosing: Xanthine containing food or drinks such as cola, chocolate, coffee or tea, citrus fruits or items (lime, lemon and orange), alcohol and any other food/beverage known to have interactions as deemed by the investigator.
- Volunteers who are dysphagic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product
This study will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg.
The study will be performed at a single site with 10 subjects. Participants will take 1 tablet 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 7 days between each study period.
Read the detailed description
The primary objective of the study is to investigate the relative bioavailability of Estradiol Valerate and Dienogest 2mg/ 2mg of 1 tablet formulations with Estradiol Valerate and Dienogest 2mg/ 2mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
- Test Product: Product manufactured by Laboratorios Andromaco S.A.
- Reference Product: Climodien [Trademark], product Bayer plc. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0 0-t) and from time zero to infinite (AUC0 0-∞), and maximum plasma concentration (Cmax) for total Estradiol and Dienogest will be determined. Participants will be confined in the study site for approximately 42 hours during the entire study (for 10 hours pre-dosing and for 32 hours post dosing in both periods) during which pharmacokinetic (PK) blood samples will be obtained. 26 blood samples will be taken up to 72 hours after the administration in each period. The washout period between the two study periods will be at least 7 days. The samples from each participant will be analyzed with validated LC-MS/MS method for estimation of Estradiol and Dienogest in plasma. The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events.
- Conditions
- Bioequivalence
- Being tested
- Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet, Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tabletDrug
Investigational Medicinal Product
Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tabletDrug
Climodien (Bayer plc.)
| Study group | Role | What they receive |
|---|---|---|
| Estradiol Valerate and Dienogest Test Product. | Experimental | Participants will receive one tablet of the test formulation containing Estradiol Valerate and Dienogest 2 mg/ 2 mg.The tablet will be taken with water and in a fasting condition. Receives: Drug: Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet |
| Estradiol Valerate and Dienogest Referent Product | Active comparator | Participants will receive one tablet of the marketed reference containing Estradiol Valerate and Dienogest 2 mg/ 2 mg. The tablet will be taken with water and in a fasting condition. Receives: Drug: Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Estradiol Valerate: area under the plasma concentration-time curve from 0 to time t (AUC0-72)
26 samples up to 72 hours will be taken after the administration in each period
Measured: From tablet intake and up to 72 hours after tablet intake
Total Estradiol Valerate: Maximum plasma concentration (Cmax)
26 samples up to 72 hours will be taken after the administration in each period
Measured: From tablet intake and up to 72 hours after tablet intake
Total Estradiol Valerate: Time to achieve maximum plasma concentration (tmax)
26 samples up to 72 hours will be taken after the administration in each period
Measured: From tablet intake and up to 72 hours after tablet intake
Total Dienogest: area under the plasma concentration-time curve from 0 to time t (AUC0-72)
26 samples up to 72 hours will be taken after the administration in each period
Measured: From tablet intake and up to 72 hours after tablet intake
Total Dienogest: Maximum plasma concentration (Cmax)
26 samples up to 72 hours will be taken after the administration in each period
Measured: From tablet intake and up to 72 hours after tablet intake
Total Dienogest: Time to achieve maximum plasma concentration (tmax)
26 samples up to 72 hours will be taken after the administration in each period
Measured: From tablet intake and up to 72 hours after tablet intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start12 Mar 2022
- Primary completion22 Mar 2022
- Study completion22 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Andromaco S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R. Amirtha, MD, Principal investigator, Azidus Laboratories Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332106
- Sponsor's protocol ID
- HP8833-01
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 18 Apr 2022
- 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product
- ClinicalTrials.gov ID
- NCT05332106
- Acronym / sponsor ID
- HP8833-01
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Laboratorios Andromaco S.A.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 18 Apr 2022 (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 will investigate the bioavailability in fasting healthy, adult, human post-menopausal female subjects of 1 tablet formulation containing Estradiol Valerate and Dienogest 2 mg/ 2mg.
The study will be performed at a single site with 10 subjects. Participants will take 1 tablet 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 7 days between each study period.
Detailed description
The primary objective of the study is to investigate the relative bioavailability of Estradiol Valerate and Dienogest 2mg/ 2mg of 1 tablet formulations with Estradiol Valerate and Dienogest 2mg/ 2mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
- Test Product: Product manufactured by Laboratorios Andromaco S.A.
- Reference Product: Climodien [Trademark], product Bayer plc. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters area under the plasma concentration-time curve from time zero to time t (AUC0 0-t) and from time zero to infinite (AUC0 0-∞), and maximum plasma concentration (Cmax) for total Estradiol and Dienogest will be determined. Participants will be confined in the study site for approximately 42 hours during the entire study (for 10 hours pre-dosing and for 32 hours post dosing in both periods) during which pharmacokinetic (PK) blood samples will be obtained. 26 blood samples will be taken up to 72 hours after the administration in each period. The washout period between the two study periods will be at least 7 days. The samples from each participant will be analyzed with validated LC-MS/MS method for estimation of Estradiol and Dienogest in plasma. The safety objective is to evaluate the tolerability of both formulations in subjects by collecting adverse events.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estradiol Valerate and Dienogest Test Product. | Experimental | Drug: Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tabletParticipants will receive one tablet of the test formulation containing Estradiol Valerate and Dienogest 2 mg/ 2 mg.The tablet will be taken with water and in a fasting condition. |
| Estradiol Valerate and Dienogest Referent Product | Active comparator | Drug: Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tabletParticipants will receive one tablet of the marketed reference containing Estradiol Valerate and Dienogest 2 mg/ 2 mg. The tablet will be taken with water and in a fasting condition. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy post-menopausal female literate volunteers of 40 to 65 years (both years inclusive) with BMI of 18.50 - 29.99 Kg/m2 and weight > 50 Kg.
- Healthy volunteers as evaluated by medical history, vitals and general clinical examination.
- Normal or clinically insignificant biochemical, hematological, urine and serology parameters.
- Normal or clinically insignificant ECG.
- Negative urine test for drugs of abuse and negative pregnancy test.
Key exclusion criteria (11 listed)
- History of any major surgical procedure in the past 03 months.
- History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric and hematological disorders.
- History of chronic alcoholism/ chronic smoking/ drug of abuse.
- Volunteers with known hypersensitivity to Dienogest/Estradiol Valerate or any of the excipients.
- History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing.
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 |
|---|---|---|
| Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tabletInvestigational Medicinal Product | Drug | Estradiol Valerate and Dienogest Test Product. |
| Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tabletClimodien (Bayer plc.) | Drug | Estradiol Valerate and Dienogest Referent Product |
Primary outcome
Total Estradiol Valerate: area under the plasma concentration-time curve from 0 to time t (AUC0-72)
Time frame: From tablet intake and up to 72 hours after tablet intake
26 samples up to 72 hours will be taken after the administration in each period
Total Estradiol Valerate: Maximum plasma concentration (Cmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
26 samples up to 72 hours will be taken after the administration in each period
Total Estradiol Valerate: Time to achieve maximum plasma concentration (tmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
26 samples up to 72 hours will be taken after the administration in each period
Total Dienogest: area under the plasma concentration-time curve from 0 to time t (AUC0-72)
Time frame: From tablet intake and up to 72 hours after tablet intake
26 samples up to 72 hours will be taken after the administration in each period
Total Dienogest: Maximum plasma concentration (Cmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
26 samples up to 72 hours will be taken after the administration in each period
Total Dienogest: Time to achieve maximum plasma concentration (tmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
26 samples up to 72 hours will be taken after the administration in each period
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 Apr 2022.
- 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.
R. Amirtha, MD principal investigator
Azidus Laboratories Ltd.
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 Estradiol Valerate and Dienogest 2 mg/ 2 mg Test Drug tablet and Estradiol Valerate and Dienogest 2 mg/ 2 mg Reference Product tablet in people with Bioequivalence, run by Laboratorios Andromaco S.A. at 1 site in India.
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 7 inclusion and 11 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 Apr 2022. 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 India. 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?
Total Estradiol Valerate: area under the plasma concentration-time curve from 0 to time t (AUC0-72) (time frame: From tablet intake and up to 72 hours after tablet intake). The study lists 6 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 Apr 2022.