BioequivalencePhase 1NCT01340625
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
A Phase 1 study testing Norethindrone/Ethinyl Estradiol and Ovcon® 35 Fe in people with Bioequivalence, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 *… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Norethindrone/Ethinyl Estradiol and Ovcon® 35 Fe
- 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 siteUnited States
- Study dates
- Dec 2006to Jan 2007
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers who have been informed of the nature of the study and agree to read, review, and sign the informed consent document prior to Period I dosing.
- Volunteers who have completed the screening process within 28 days prior to Period I dosing.
- Volunteers who are healthy adult women 18-35 years of age, inclusive, at the time of dosing.
- Volunteers who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weight at least 110 lbs.
- Volunteers who are healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram, clinical laboratory assessments, and by general observations. The physical examination will also include a gynecological exam. If the subject has completed an acceptable Papanicolaou smear and gynecological exam in the previous 12 months and documentation of acceptable results are provided, both will be deferred. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
- Volunteers must practice an acceptable non-hormonal birth control method as judged by the investigator(s) at least 14 days prior to Period I dosing, throughout the study, and until 14 days after second period dosing.
Who cannot join
- Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
- Volunteers who report taking any oral contraceptives including estrogen and progestin combined pills and progestin only pills or patch within 28 days prior to Period I dosing, using injectable contraceptives within 6 months of first period dosing.
- Volunteers who have ever had progestational hormone implants.
- Volunteers who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems or psychiatric disease as determined by the clinical investigator(s).
- Volunteers who report any presence or history of migraines or severe headaches.
- Volunteers who have systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 45 or over 90 mmHg will be excluded from the study.
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- Volunteers who have a history of thrombotic disorders or have ever had cerebrovascular accident or transient ischemic attacks.
- Volunteers with a history of breast cancer or undiagnosed breast nodules, active malignancies or undiagnosed vaginal bleeding.
- Volunteers having other conditions that may be aggravated by fluid retention (as determined by principal investigator).
- Volunteers who have a history of jaundice with previous use of oral contraceptives or any other kinds of hormonal contraceptives.
- Volunteers whose clinical laboratory test values fall outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
- Volunteers who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Volunteers who report a history of allergic response(s) to norethindrone/ethinyl estradiol or progestin/estrogens or related drugs.
- Volunteers who report the use of any systemic prescription medication in the 14 days prior to Period I dosing (with the exception of hormonal contraceptives).
- Volunteers with a history of clinically significant allergies including drug allergies.
- Volunteers who report a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Volunteers who report a history of drug or alcohol addiction or abuse within the past year.
- Volunteers who demonstrate a positive drug abuse screen for this study prior to Period I dose administration.
- Volunteers who currently use or have used tobacco products within 30 days prior to Period I dosing.
- Volunteers who report donating greater that 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for 4 weeks after completing the study.
- Volunteers who report donating plasma within 30 days prior to Period I dosing. All subjects will be advised not to donate plasma for 4 weeks after completing the study.
- Volunteers who demonstrate a positive pregnancy screen.
- Volunteers who are currently pregnant of breastfeeding.
- Volunteers who are using or have used within the 3 months preceding Period I dosing any vaginally administered estrogen or progestin-containing products.
- Any volunteer who engages in unprotected sexual intercourse during the time interval starting 14 days prior to first period dosing and until 14 days after the Period II dosing.
- Volunteers who have had a hysterectomy or oophorectomy (unilateral or bilateral).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of 0.4 mg/35 Mcg Norethindrone and Ethinyl Estradiol Chewable Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 * 0.4 mg/35 mcg chewable tablets) in healthy female adult volunteers administered under fasting conditions.
- Conditions
- Bioequivalence
- Being tested
- Norethindrone/Ethinyl Estradiol, Ovcon® 35 Fe
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norethindrone/Ethinyl EstradiolDrug
Also called Zeosa®
0.4 mg/35 mcg Chewable Tablets
Ovcon® 35 FeDrug
Also called Femcon® Fe, Norethindrone/Ethinyl Estradiol (generic name)
0.4 mg/35 mcg Chewable Tablets
| Study group | Role | What they receive |
|---|---|---|
| Investigational Test Product | Experimental | Norethindrone/Ethinyl Estradiol 0.4 mg/35 mcg Chewable Tablets (Teva) Receives: Drug: Norethindrone/Ethinyl Estradiol |
| Reference Listed Drug | Active comparator | Ovcon® 35 Fe 0.4 mg/35 mcg Chewable Tablets (Warner Chilcott) Receives: Drug: Ovcon® 35 Fe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Norethindrone
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
Measured: Blood samples collected over a 60 hour period.
AUC0-t of Norethindrone
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Measured: Blood samples collected over a 60 hour period.
AUC0-inf of Norethindrone
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
Measured: Blood samples collected over a 60 hour period.
Cmax of Ethinyl Estradiol
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
Measured: Blood samples collected over a 60 hour period.
AUC0-t of Ethinyl Estradiol
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
Measured: Blood samples collected over a 60 hour period.
AUC0-inf of Ethinyl Estradiol
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).
Measured: Blood samples collected over a 60 hour period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startDec 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340625
- Sponsor's protocol ID
- R06-1188
- Status last verified
- Apr 2011
- First submitted
- 20 Apr 2011
- Last updated
- 25 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 0.4 mg/35 Mcg Norethindrone and Ethinyl Estradiol Chewable Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01340625
- Acronym / sponsor ID
- R06-1188
- Conditions
- Bioequivalence
- Keywords
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Posted 25 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets manufactured by Warner Chilcott Company, Inc., following a single oral dose (2 * 0.4 mg/35 mcg chewable tablets) in healthy female adult volunteers administered under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Test Product | Experimental | Drug: Norethindrone/Ethinyl EstradiolNorethindrone/Ethinyl Estradiol 0.4 mg/35 mcg Chewable Tablets (Teva) |
| Reference Listed Drug | Active comparator | Drug: Ovcon® 35 FeOvcon® 35 Fe 0.4 mg/35 mcg Chewable Tablets (Warner Chilcott) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteers who have been informed of the nature of the study and agree to read, review, and sign the informed consent document prior to Period I dosing.
- Volunteers who have completed the screening process within 28 days prior to Period I dosing.
- Volunteers who are healthy adult women 18-35 years of age, inclusive, at the time of dosing.
- Volunteers who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weight at least 110 lbs.
- Volunteers who are healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram, clinical laboratory assessments, and by general observations. The physical examination will also include a gynecological exam. If the subject has completed an acceptable Papanicolaou smear and gynecological exam in the previous 12 months and documentation of acceptable results are provided, both will be deferred. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
Key exclusion criteria (26 listed)
- Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
- Volunteers who report taking any oral contraceptives including estrogen and progestin combined pills and progestin only pills or patch within 28 days prior to Period I dosing, using injectable contraceptives within 6 months of first period dosing.
- Volunteers who have ever had progestational hormone implants.
- Volunteers who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic systems or psychiatric disease as determined by the clinical investigator(s).
- Volunteers who report any presence or history of migraines or severe headaches.
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 |
|---|---|---|
| Norethindrone/Ethinyl EstradiolAlso: Zeosa®0.4 mg/35 mcg Chewable Tablets | Drug | Investigational Test Product |
| Ovcon® 35 FeAlso: Femcon® Fe, Norethindrone/Ethinyl Estradiol (generic name)0.4 mg/35 mcg Chewable Tablets | Drug | Reference Listed Drug |
Primary outcome
Cmax of Norethindrone
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Norethindrone
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf of Norethindrone
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).
Cmax of Ethinyl Estradiol
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).
AUC0-t of Ethinyl Estradiol
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).
AUC0-inf of Ethinyl Estradiol
Time frame: Blood samples collected over a 60 hour period.
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Norethindrone/Ethinyl Estradiol and Ovcon® 35 Fe in people with Bioequivalence, run by Teva Pharmaceuticals USA at 1 site in United States.
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 26 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 25 May 2011. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Norethindrone (time frame: Blood samples collected over a 60 hour period.). 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 25 May 2011.