BioequivalencePhase 1NCT04194905
Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product
A Phase 1 study testing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test Product and Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference Product in people with Bioequivalence, run by Laboratorios Andromaco S.A. at 1 site in Chile.
Trial summary
This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The Pilot 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 0.1 mg and Ethinyl estradiol 0.02 mg Test Product and Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference Product
- 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 siteChile
- Study dates
- 21 Nov 2020to 15 Dec 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 staff or 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 pharmacological therapy (except over the counter medication use 7 days prior the study)
Show all 17Show fewer
- Hypersensitivity to the study drug or other related compounds, history of serious adverse reactions or hypersensitivity to any medication
- Use, during 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 food containing xanthine 24 hours prior each administration of study medication until the last sample of each period
- History of any significant cardiovascular disease
- Acute disease that generates significant physiological changes from the start of the selection until the end of the study
- HIV, Hepatitis B and/or C positive
- Presence or history of thrombophlebitis, thrombosis or thromboembolic disorder, deep vein thrombosis, pulmonary embolism or known coagulopathy.
- Donation or loss of a significant volume (more tan 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 0.1 mg/0.02 mg Coated Tablets With Regards to the Marketed Reference Product
This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg.
The Pilot 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 0.1 mg and Ethinyl estradiol 0.02 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: Level [Trademark], product of Biolab Sanus Farmaceutica Ltda.
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-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 high performance 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 0.1 mg and Ethinyl estradiol 0.02 mg Test Product, Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference Product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test ProductDrug
Also called Investigational Medicinal Product
Coated Tablets
Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference ProductDrug
Also called Level (Trademark)
Coated Tablets
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel Ethinyl estradiol Test Product | Experimental | Participants will receive two tablets of the test formulation containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The tablets will be taken with water and in a fasting condition. Receives: Drug: Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test Product |
| Levonorgestrel Ethinyl estradiol Reference Product | Active comparator | Participants will receive two tablets of the marketed reference formulation containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The tablets will be taken with water and in a fasting condition. Receives: Drug: Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 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. The Cmax will be calculated.
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. The Cmax will be calculated.
Measured: From tablet intake and up to 72 hours after tablet intake
Secondary outcomes (2)
Total Levonorgestrel: Time to achieve maximum plasma concentration (tmax)
19 samples up to 72 hours will be taken after the administration in each period. The tmax will be calculated.
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. The tmax will be calculated.
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 posted11 Dec 2019
- Study start21 Nov 2020
- Primary completion21 Nov 2020
- Study completion15 Dec 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Andromaco S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director Laboratorios Andromaco, Study director, Grünenthal Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194905
- Sponsor's protocol ID
- HP8814-02
- Other IDs
- 013-19-V1-080519
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2019
- 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 0.1 mg/0.02 mg Coated Tablets With Regards to the Marketed Reference Product
- ClinicalTrials.gov ID
- NCT04194905
- Acronym / sponsor ID
- HP8814-02
- 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
- 21 Nov 2020 (actual)
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 11 Dec 2019 (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 Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg.
The Pilot 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 0.1 mg and Ethinyl estradiol 0.02 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: Level [Trademark], product of Biolab Sanus Farmaceutica Ltda.
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-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 high performance 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 Ethinyl estradiol Test Product | Experimental | Drug: Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test ProductParticipants will receive two tablets of the test formulation containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The tablets will be taken with water and in a fasting condition. |
| Levonorgestrel Ethinyl estradiol Reference Product | Active comparator | Drug: Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference ProductParticipants will receive two tablets of the marketed reference formulation containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The tablets will be taken with water and in a fasting condition. |
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 staff or 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 0.1 mg and Ethinyl estradiol 0.02 mg Test ProductAlso: Investigational Medicinal ProductCoated Tablets | Drug | Levonorgestrel Ethinyl estradiol Test Product |
| Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference ProductAlso: Level (Trademark)Coated Tablets | Drug | Levonorgestrel 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. The Cmax will be calculated.
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. The Cmax will be calculated.
2 secondary outcomes
Total Levonorgestrel: Time to achieve maximum plasma concentration (tmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
Total Ethinyl estradiol: Time to achieve maximum plasma concentration (tmax)
Time frame: From tablet intake and up to 72 hours after tablet intake
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.
Study Director Laboratorios Andromaco study director
Grünenthal Group
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 0.1 mg and Ethinyl estradiol 0.02 mg Test Product and Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 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 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 10 Feb 2021.