Therapeutic EquivalencyPhase 1NCT05282940
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product
A Phase 1 study testing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug and Microgynon CD in people with Therapeutic Equivalency, run by Laboratorios Andromaco S.A. at 1 site in India.
Trial summary
This study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The study will be performed at a single site with 36 subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug and Microgynon CD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndia
- Study dates
- 26 Feb 2022to 8 Apr 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy non-pregnant, non-breast feeding female literate volunteers of 18 to 45 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 EC.
- Negative urine test for drugs of abuse, negative pregnancy test and do not plan to become pregnant during course of the study and for 03 months after completion of study.
- 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 Ethinyl-estradiol and Levonorgestrel or any of the excipients.
- History of consumption of tobacco containing products within 48 hours prior to proposed time of dosing
- Volunteer who are positive for hepatitis B surface antigen, anti-hepatitis C antibody, treponemal antibodies and human immunodeficiency virus (HIV 1\&2) antibodies.
Show all 11Show fewer
- 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 Ethinyl-estradiol and Levonorgestrel 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.
- Volunteer 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 Levonorgestrel and Ethinyl Estradiol 15.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product
This study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The study will be performed at a single site with 36 subjects. Participants will take 2 tablets 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 14 days between each study period.
Read the detailed description
The primary objective of the study is to investigate the relative bioavailability of Levonorgestrel and Ethinyl estradiol of 2 tablet formulations with Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
- Test Product: Product manufactured by Laboratorios Andrómaco S.A.
- Reference Product: Microgynon [Trademark], product of Bayer AG, Brasil. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters área under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to infinite (AUC0-∞), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined. Participants will be confined in the study site for approximately 34 hours during each study period (for 10 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 21 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 48 h, and 72 h postdose. The washout period between the two study periods will be at least 14 days. A validated LC-MS/MS bio-analytical method will be used for estimation of plasma levels of Ethinyl-estradiol and Levonorgestrel. The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.
- Conditions
- Therapeutic Equivalency
- Being tested
- Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug, Microgynon CD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test DrugDrug
Investigational Medicinal Product
Microgynon CDDrug
Microgynon CD will be used as a comparator drug for the BE study. Other Name: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Drug
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel and Ethinyl estradiol Test Product | Experimental | Participants will receive two tablets of the test formulation containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water. Receives: Drug: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug |
| Levonorgestrel and Ethinyl estradiol Reference Product | Active comparator | Participants will receive two tablets of the test marketed reference formulation containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water. Receives: Drug: Microgynon CD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)
21 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 Levonorgestrel: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)
21 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 Ethinyl estradiol: Maximum plasma concentration (Cmax)
21 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 Levonorgestrel: Maximum plasma concentration (Cmax)
21 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 Ethinyl estradiol: Time to achieve maximum plasma concentration (tmax)
21 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 Levonorgestrel: Time to achieve maximum plasma concentration (tmax)
21 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 posted16 Mar 2022
- Study start26 Feb 2022
- Primary completion15 Mar 2022
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Andromaco S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282940
- Sponsor's protocol ID
- HP8814-03
- Status last verified
- Apr 2022
- First submitted
- 25 Feb 2022
- Last updated
- 2 Jun 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 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of a Formulation of Levonorgestrel and Ethinyl Estradiol 15.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product
- ClinicalTrials.gov ID
- NCT05282940
- Acronym / sponsor ID
- HP8814-03
- Conditions
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Laboratorios Andromaco S.A.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 16 Mar 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 women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The study will be performed at a single site with 36 subjects. Participants will take 2 tablets 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 14 days between each study period.
Detailed description
The primary objective of the study is to investigate the relative bioavailability of Levonorgestrel and Ethinyl estradiol of 2 tablet formulations with Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg and to demonstrate bioequivalence of both formulations in terms of rate and extent of absorption:
- Test Product: Product manufactured by Laboratorios Andrómaco S.A.
- Reference Product: Microgynon [Trademark], product of Bayer AG, Brasil. The 90% confidence intervals for the intra-subject coefficient of variation (Test versus Reference Product) for the main pharmacokinetic parameters área under the plasma concentration-time curve from time zero to time t (AUC0-t) and from time zero to infinite (AUC0-∞), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined. Participants will be confined in the study site for approximately 34 hours during each study period (for 10 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 21 blood samples will be taken up to 24 hours after the administration in each period. Participants will return to the site to provide additional blood samples at 48 h, and 72 h postdose. The washout period between the two study periods will be at least 14 days. A validated LC-MS/MS bio-analytical method will be used for estimation of plasma levels of Ethinyl-estradiol and Levonorgestrel. The safety objective is to evaluate the tolerability of both formulations in women 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 |
|---|---|---|
| Levonorgestrel and Ethinyl estradiol Test Product | Experimental | Drug: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test DrugParticipants will receive two tablets of the test formulation containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water. |
| Levonorgestrel and Ethinyl estradiol Reference Product | Active comparator | Drug: Microgynon CDParticipants will receive two tablets of the test marketed reference formulation containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The tablets will be taken with water. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy non-pregnant, non-breast feeding female literate volunteers of 18 to 45 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 EC.
- Negative urine test for drugs of abuse, negative pregnancy test and do not plan to become pregnant during course of the study and for 03 months after completion of study.
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 Ethinyl-estradiol and Levonorgestrel 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 |
|---|---|---|
| Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test DrugInvestigational Medicinal Product | Drug | Levonorgestrel and Ethinyl estradiol Test Product |
| Microgynon CDMicrogynon CD will be used as a comparator drug for the BE study. Other Name: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Drug | Drug | Levonorgestrel and Ethinyl estradiol Reference Product |
Primary outcome
Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)
Time frame: From tablet intake and up to 72 hours after tablet intake
21 samples up to 72 hours will be taken after the administration in each period
Total Levonorgestrel: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)
Time frame: From tablet intake and up to 72 hours after tablet intake
21 samples up to 72 hours will be taken after the administration in each period
Total Ethinyl estradiol: Maximum plasma concentration (Cmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
21 samples up to 72 hours will be taken after the administration in each period
Total Levonorgestrel: Maximum plasma concentration (Cmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
21 samples up to 72 hours will be taken after the administration in each period
Total Ethinyl estradiol: Time to achieve maximum plasma concentration (tmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
21 samples up to 72 hours will be taken after the administration in each period
Total Levonorgestrel: Time to achieve maximum plasma concentration (tmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
21 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 2 Jun 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug and Microgynon CD in people with Therapeutic Equivalency, 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 2 Jun 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 Ethinyl estradiol: area under the plasma concentration-time curve from 0 to 72 hours (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 2 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.