HealthyPhase 1NCT01760980
Pivotal Bioequivalence Study of Exemestane 25 mg Tablets Under Fasting Conditions in Healthy Subjects
A Phase 1 study testing Reference product (A) Aromasin (Exemestane) and Test product (B) Exemestane in people with Healthy, run by Actavis Inc. at 1 site in South Africa.
Trial summary
The objective of this study is to assess the bioequivalence of the test product, Exemestane 25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin® (exemestane) 25 mg tablets of Pharmacia \& Upjohn Company, Division of Pfizer Inc., New York, United States of America in healthy male and… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Reference product (A) Aromasin (Exemestane) and Test product (B) Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2012to Dec 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects, 18 to 55 years of age and postmenopausal female subjects, 18 years to not older than 75 years of age (inclusive at time of screening).
- Body Mass Index (BMI) between 19 and 33 kg/m2 (relates to a body mass within 15% of ideal body mass for height and age).
- Body mass not less than 50 kg.
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
- Non-smoker or mild to moderate smoker (≤ 10 cigarettes daily).
- Females, if:
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- Serum follicle-stimulating hormone (FSH) ≥ 25.8 mIU/mL AND a serum estradiol level of ≤ 54.7 pg/mL at screening.
- Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal.
- Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased, but if not increasing upon repeat, the female will be included in the study.
- Not on thyroid hormone replacement therapy or on stable thyroid hormone replacement therapy for at least 3 months before the first administration of IMP.
- Not on statin therapy or on stable statin therapy for at least 3 months before the first administration of IMP.
- Blood pressure measurements are within the acceptable ranges; or, if diagnosed with hypertension, are on stable therapy for at least 3 months before the first administration of IMP.
- Note: Treatment with calcium channel blockers is NOT allowed.
- Written consent given for participation in the study. -
Who cannot join
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females.
- History of regular exposure to substances of abuse (other than alcohol) within the past year.
- Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks prior to the first administration of IMP, except for medication allowed per inclusion criteria (Section 7.3.1) or if the medication will not affect the outcome of the study in the opinion of the investigator.
- Female hormone replacement therapy (or other medicine containing estrogen, including health food products for menopausal symptoms, as these may contain natural estrogens), within 2 weeks prior to the first administration of IMP.
- Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks before the first administration of IMP in this study.
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- Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of IMP.
- Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
- A major illness during the 3 months before commencement of the screening period.
- History of hypersensitivity or allergy to the IMP or its excipients or any related medication.
- History of bronchial asthma or any other bronchospastic disease within the past 5 years.
- History of epilepsy.
- History of porphyria.
- Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
- Systolic blood pressure > 150 mmHg or < 95 mmHg, and/or diastolic blood pressure > 95 mmHg or < 50 mmHg in either the supine or standing position at screening.
- Resting pulse of > 100 beats per minute or < 45 beats per minute in either the supine or standing position at screening.
- Positive serology testing for human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C or syphilis.
- Positive urine screen for drugs of abuse.
- Positive pregnancy test.
- Female subjects of premenopausal endocrine status, including pregnant and lactating women.
- Clinically diagnosed peptic ulceration within the past 5 years.
- History of bleeding disorders.
- Vegetarian or any abnormal diet (for whatever reason).
- Any specific investigational product safety concern. -
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)
Bloemfontein, 9301
About this study
The objective of this study is to assess the bioequivalence of the test product, Exemestane 25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin® (exemestane) 25 mg tablets of Pharmacia \& Upjohn Company, Division of Pfizer Inc., New York, United States of America in healthy male and postmenopausal female subjects, under fasting conditions
- Conditions
- Healthy
- Being tested
- Reference product (A) Aromasin (Exemestane), Test product (B) Exemestane
- Keywords
- Rate and extend of absorption of Exemestane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference product (A) Aromasin (Exemestane)Drug
Also called Aromasin (Exemestane) 25 mg tablets
Aromasin tablets will be administered under fasting conditions on two occasions
Test product (B) ExemestaneDrug
Also called Exemestane 25 mg tablets
Exemestane tablets will be administered under fasting conditions on one occasion
| Study group | Role | What they receive |
|---|---|---|
| Test product (B) | Experimental | B: Subjects receive Exemestane 25 mg tablets under fasting conditions Receives: Drug: Test product (B) Exemestane |
| Reference product (A) | Active comparator | A: Subjects receive Aromasin 25 mg tablets on two occasions under fasting conditions Receives: Drug: Reference product (A) Aromasin (Exemestane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt, AUCinf and Cmax of Exemestane 25 mg tablets
Measured: 0, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 12.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post does
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Why it stopped: Development halted by management
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760980
- Sponsor's protocol ID
- PXL209003
- Status last verified
- Jul 2019
- First submitted
- 2 Jan 2013
- Last updated
- 5 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Bioequivalence Study of Exemestane 25 mg Tablets Under Fasting Conditions in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01760980
- Acronym / sponsor ID
- PXL209003
- Conditions
- Healthy
- Keywords
- Rate and extend of absorption of Exemestane
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Development halted by management
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Jan 2013 (estimated)
- 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.
The objective of this study is to assess the bioequivalence of the test product, Exemestane 25 mg tablets of Actavis Group PTC ehf. Iceland, and the reference product, Aromasin® (exemestane) 25 mg tablets of Pharmacia \& Upjohn Company, Division of Pfizer Inc., New York, United States of America in healthy male and postmenopausal female subjects, under fasting conditions
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product (B) | Experimental | Drug: Test product (B) ExemestaneB: Subjects receive Exemestane 25 mg tablets under fasting conditions |
| Reference product (A) | Active comparator | Drug: Reference product (A) Aromasin (Exemestane)A: Subjects receive Aromasin 25 mg tablets on two occasions under fasting conditions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy male subjects, 18 to 55 years of age and postmenopausal female subjects, 18 years to not older than 75 years of age (inclusive at time of screening).
- Body Mass Index (BMI) between 19 and 33 kg/m2 (relates to a body mass within 15% of ideal body mass for height and age).
- Body mass not less than 50 kg.
- Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
- Non-smoker or mild to moderate smoker (≤ 10 cigarettes daily).
Key exclusion criteria (24 listed)
- Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
- Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females.
- History of regular exposure to substances of abuse (other than alcohol) within the past year.
- Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks prior to the first administration of IMP, except for medication allowed per inclusion criteria (Section 7.3.1) or if the medication will not affect the outcome of the study in the opinion of the investigator.
- Female hormone replacement therapy (or other medicine containing estrogen, including health food products for menopausal symptoms, as these may contain natural estrogens), within 2 weeks prior to the first administration of IMP.
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 |
|---|---|---|
| Reference product (A) Aromasin (Exemestane)Also: Aromasin (Exemestane) 25 mg tabletsAromasin tablets will be administered under fasting conditions on two occasions | Drug | Reference product (A) |
| Test product (B) ExemestaneAlso: Exemestane 25 mg tabletsExemestane tablets will be administered under fasting conditions on one occasion | Drug | Test product (B) |
Primary outcome
AUCt, AUCinf and Cmax of Exemestane 25 mg tablets
Time frame: 0, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 12.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post does
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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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 Reference product (A) Aromasin (Exemestane) and Test product (B) Exemestane in people with Healthy, run by Actavis Inc. at 1 site in South Africa.
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 14 inclusion and 24 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: withdrawn, as of the sponsor's last update on 5 Jul 2019. 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 South Africa. 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 was withdrawn before enrolling participants, so there are no results.
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?
AUCt, AUCinf and Cmax of Exemestane 25 mg tablets (time frame: 0, 0.333, 0.500, 0.750, 1.000, 1.250, 1.500, 1.750, 2.000, 2.500, 3.000, 3.500, 4.000, 6.000, 8.000, 12.000, 24.000, 36.000, 48.000, 72.000 and 96.000 hours post does). 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 5 Jul 2019.