HealthyPhase 1NCT00648063
Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
A Phase 1 study testing Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Jan 2006
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 40 years or older.
- Sex: Females only.
- Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN BIOAVAILABILITY PROTOCOLS).
- Absence of menses for one year for postmenopausal subjects, or at least 6 weeks for oophorectomized subjects. (For oophorectomized subjects, an operative report documenting bilateral oophorectomy and surgical pathology report documenting the absence of malignant disease.)
- Baseline FSH and 17β-estradiol serum levels consistent with postmenopausal status confirmed within 72 hours of initiation of study medication (FSH greater than or equal to 40 mIU/mL; 17β-estradiol less than or equal to 31 pg/mL).
- All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, Hepatitis B, Hepatitis C and HIV tests, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication.
Show all 10Show fewer
- The physical examination shall include pelvic and breast exams.
- Pelvic findings should be consistent with hypoestrogenemia.
- A mammogram will be required if not performed within the last 12 months.
- A Papanicolaou ("Pap") smear will be required on subjects with an intact uterus and cervix if not performed within the last 6 months.
Who cannot join
- Institutionalized subjects will not be used.
- Social Habits:
- Use of any tobacco-containing products within 1 year of start of study.
- Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
- Any recent, significant change in dietary or exercise habits.
Show all 24Show fewer
- A positive test for any drug included in the urine drug screen.
- History of drug and/or alcohol abuse.
- Medications:
- Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Use hormonal replacement therapy within 3 months prior to the initial dose of study medication.
- Diseases:
- History of any significant chronic disease such as (but not limited to): 1. Thrombotic disorders. 2. Coronary artery or cerebrovascular disease. 3. Liver, kidney or gallbladder dysfunction/disorder(s). 4. Diabetes or any other endocrinological disease. 5. Estrogen-dependent neoplasia. 6. Postmenopausal uterine bleeding. 7. Endometrial hyperplasia.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- A positive HIV, Hepatitis B, or Hepatitis C test.
- Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to letrozole, any of the inactive ingredients.
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Dose Fasting Bioequivalence Study of Letrozole Tablets (2.5 mg; Mylan) and Femara® Tablets (2.5 mg; Novartis) in Healthy Postmenopausal Female Volunteers
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions.
- Conditions
- Healthy
- Being tested
- Letrozole Tablets 2.5 mg, Femara® Tablets 2.5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole Tablets 2.5 mgDrug
2.5mg, single dose fasting
Femara® Tablets 2.5 mgDrug
2.5mg, single dose fasting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Letrozole Tablets 2.5 mg Receives: Drug: Letrozole Tablets 2.5 mg |
| 2 | Active comparator | Femara® Tablets 2.5 mg Receives: Drug: Femara® Tablets 2.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Measured: Blood collections through 216 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startNov 2005
- Primary completionDec 2005
- Study completionJan 2006
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence Galitz, M.D., Principal investigator, SFBC International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00648063
- Sponsor's protocol ID
- LETR-05122
- Status last verified
- Nov 2009
- First submitted
- 30 Mar 2008
- Last updated
- 1 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Fasting Bioequivalence Study of Letrozole Tablets (2.5 mg; Mylan) and Femara® Tablets (2.5 mg; Novartis) in Healthy Postmenopausal Female Volunteers
- ClinicalTrials.gov ID
- NCT00648063
- Acronym / sponsor ID
- LETR-05122
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 1 Apr 2008 (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 was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Letrozole Tablets 2.5 mgLetrozole Tablets 2.5 mg |
| 2 | Active comparator | Drug: Femara® Tablets 2.5 mgFemara® Tablets 2.5 mg |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 40 years or older.
- Sex: Females only.
- Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN BIOAVAILABILITY PROTOCOLS).
- Absence of menses for one year for postmenopausal subjects, or at least 6 weeks for oophorectomized subjects. (For oophorectomized subjects, an operative report documenting bilateral oophorectomy and surgical pathology report documenting the absence of malignant disease.)
- Baseline FSH and 17β-estradiol serum levels consistent with postmenopausal status confirmed within 72 hours of initiation of study medication (FSH greater than or equal to 40 mIU/mL; 17β-estradiol less than or equal to 31 pg/mL).
Key exclusion criteria (24 listed)
- Institutionalized subjects will not be used.
- Social Habits:
- Medications:
- Diseases:
- Abnormal and clinically significant laboratory test results:
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 |
|---|---|---|
| Letrozole Tablets 2.5 mg2.5mg, single dose fasting | Drug | 1 |
| Femara® Tablets 2.5 mg2.5mg, single dose fasting | Drug | 2 |
Primary outcome
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
Time frame: Blood collections through 216 hours
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 1 Dec 2009.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Lawrence Galitz, M.D. principal investigator
SFBC International
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 Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg in people with Healthy, run by Mylan Pharmaceuticals Inc 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 10 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: finished, as of the sponsor's last update on 1 Dec 2009. 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?
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?
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. (time frame: Blood collections through 216 hours). 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 1 Dec 2009.