BioequivalencePhase 1NCT04230070
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 Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Product in people with Bioequivalence, run by Laboratorios Andromaco S.A. at 1 site in Chile.
Trial summary
This Pivotal study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal study will be performed at a single site with 30 subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug and Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChile
- Study dates
- 24 Oct 2020to 17 Nov 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant and non-breastfeeding women
- Women of childbearing age with an acceptable form of contraception during the study
- 18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or equal to 29.99
- Non-smoking or smoke only 3 cigarettes every 7 days
- With results of laboratory tests, electrocardiogram and chest radiography in normal and / or negative or abnormal ranges but without clinical relevance and declared suitable for study by the doctor after the physical examination
- Capable to understand the Informed Consent Form
Who cannot join
- Study site or sponsor staff or any of their family members
- With history of drug and/or alcohol abuse
- Smokers more tan 3 cigarettes every 7 days
- Vitamin supplements intake 7 days prior to the administration of the medications under study
- Any recent change in eating habits or physical exercise
- Using of a pharmacological therapy (except over the counter medication use 7 days prior to the study)
Show all 17Show fewer
- Hypersensitivity to the study drug or to other chemically related compounds, history of serious adverse reactions or hypersensitivity to any medication
- Use, during the 28 days prior to the start of the study, of medications known to alter liver enzyme activity
- Consumption of beverages or food containing grapefruit or pink grapefruit, within 7 days prior to each administration of the study medication and consumption of alcohol, caffeine or beverages or foods containing xanthines 24 hours before each administration of the study medication until the last sample of each period
- History of any significant cardiovascular disease
- Acute disease that generates significant physiological changes from the time of selection until the end of the study
- HIV, Hepatitis B and/or C positive
- Presence or history of thrombophlebitis, thrombosis or thromboembolic disorders, deep vein thrombosis, pulmonary embolism or known coagulopathy.
- Donation or loss of a significant volume (more than 100 mL) of blood or plasma or platelets during the 3 months prior to the start of the study
- Subjects who have participated in any type of clinical study during the 3 months prior to the start of the study
- History of any gastrointestinal surgery that could affect drug absorption
- Presence of fainting history or fear to blood collection
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 Pivotal study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal study will be performed at a single site with 30 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, Germany. 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 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined.
Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 16 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. The samples from each participant will be analyzed with 2 methods of highperformance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel and Ethinyl estradiol in plasma.
The safety objective is to evaluate the tolerability of both formulations in women by collecting adverse events.
- Conditions
- Bioequivalence
- Being tested
- Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug, Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Product
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
Also called Investigational Medicinal Product
Bioequivalence
Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference ProductDrug
Also called Microgynon CD (Trademark)
Bioequivalence
| 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 marketed reference 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 Reference Product |
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)
19 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)
19 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: area under the plasma concentration-time curve from 0 to time t (AUC0-t)
19 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 time t (AUC0-t)
19 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)
19 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)
19 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)
19 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)
19 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 Jan 2020
- Study start24 Oct 2020
- Primary completion31 Oct 2020
- Study completion17 Nov 2020
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
- 30 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
- NCT04230070
- Sponsor's protocol ID
- HP8814-01
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2020
- Last updated
- 10 Feb 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 10 Feb 2021. 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
- NCT04230070
- Acronym / sponsor ID
- HP8814-01
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Laboratorios Andromaco S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 18 Jan 2020 (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 Pivotal study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal study will be performed at a single site with 30 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, Germany. 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 72 hours (AUC0-72), and maximum plasma concentration (Cmax) for total Levonorgestrel and Ethinyl estradiol will be determined.
Participants will be confined in the study site for approximately 36 hours during each study period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK) blood samples will be obtained. 16 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. The samples from each participant will be analyzed with 2 methods of highperformance liquid chromatography-tandem mass spectrometry bioanalytical assays to quantify total Levonorgestrel and Ethinyl estradiol in plasma.
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: Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference ProductParticipants will receive two tablets of the 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 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-pregnant and non-breastfeeding women
- Women of childbearing age with an acceptable form of contraception during the study
- 18 to 55 years old inclusive; BMI greater than or equal to 18.51 and less than or equal to 29.99
- Non-smoking or smoke only 3 cigarettes every 7 days
- With results of laboratory tests, electrocardiogram and chest radiography in normal and / or negative or abnormal ranges but without clinical relevance and declared suitable for study by the doctor after the physical examination
Key exclusion criteria (17 listed)
- Study site or sponsor staff or any of their family members
- With history of drug and/or alcohol abuse
- Smokers more tan 3 cigarettes every 7 days
- Vitamin supplements intake 7 days prior to the administration of the medications under study
- Any recent change in eating habits or physical exercise
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 DrugAlso: Investigational Medicinal ProductBioequivalence | Drug | Levonorgestrel and Ethinyl estradiol Test Product |
| Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference ProductAlso: Microgynon CD (Trademark)Bioequivalence | 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
19 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
19 samples up to 72 hours will be taken after the administration in each period
Total Ethinyl estradiol: area under the plasma concentration-time curve from 0 to time t (AUC0-t)
Time frame: From tablet intake and up to 72 hours after tablet intake
19 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 time t (AUC0-t)
Time frame: From tablet intake and up to 72 hours after tablet intake
19 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
19 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
19 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
19 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
19 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 10 Feb 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.
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 Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Product in people with Bioequivalence, run by Laboratorios Andromaco S.A. at 1 site in Chile.
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 6 inclusion and 17 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 10 Feb 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 Chile. 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 8 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 10 Feb 2021.