HealthyPhase 1NCT01372982
Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fed Conditions
A Phase 1 study testing Letrozole in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fed conditions. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 2008
- 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 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy post menopausal women within the age range of 40 to 69 years.
- A body mass index within 18-29.9 Kg/m2
- The postmenopausal status should be confirmed by
- Serum Estradiol concentration < 40 pg/mL.
- Serum follicle stimulating hormone FSH)concentration >30 IU/L.
- No vaginal bleeding for at least 1 year.
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- Given written informed consent to participate in the study.
- Absence of disease markers ofHIV 1 \& 2, hepatitis B \& C virus and RPR. Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
- A normal l2-lead ECG.
- A normal chest X-ray (PA view) with in six months before the date of dosing.
- Comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol.
- No history or no evidence of hypersensitivity/ idiosyncratic reaction to Letrozole and related drugs or peanut products or other ingredients of the Letrozole formulation.
- No history of significant systemic diseases.
- Non-smokers.
- No history of psychiatric disorders.
- No donation of blood (one unit or 350 mL) within 56 days prior to study check- in.
- No history of addiction to any recreational drug or drug dependence.
- No participation in any clinical study within the past 56 days.
- No receipt of any prescription drugs within 4 weeks or over-the-counter drugs (e.g.: Cold preparations, and antacid preparations vitamins and natural products used for therapeutic benefits) within 14 days prior to receiving the first dose of study medication or repeated use of drugs within the last four weeks.
- No history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to study check-in.
- No family history of neurological disorders.
- Not consumed alcohol and xanthine containing food and beverages, (chocolates, tea, coffee or cola drinks) cigarettes and tobacco products, for at least 48 hours, prior to study check in.
- Not consumed grape fruit containing food or beverages (mosumbi/sweet lime) or poppy containing foods within the 7 days prior to check-in of both periods.
- Negative results for drugs of abuse (Benzodiazepines, Cocaines, Opioids, Amphetamines,Cannabinoids and Barbiturates) in urine during the each period of study check-in.
- Negative alcohol breathe analysis during the each period of study check-in.
Who cannot join
- Subjects incapable of understanding the informed consent.
- History of suggestive of breast carcinoma, endometrial carcinoma or cervical carcinoma.
- History of suggestive of deep vein thrombosis and / or undiagnosed vaginal bleeding.
- History of thromboembolic disorders.
- History of seizures.
- History of any other major surgical procedure in the past 3 months.
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- History of diabetes mellitus and systemic hypertension.
- Past history of anaphylaxis or angioedema.
- History of porphyria, Dubin-Johnson, Rotor syndrome or any other hyperbilirubinemia syndrome.
- History of otosclerosis exacerbated during pregnancy.
- History of cardiovascular, renal, hepatic, ophthalmic,pulmonary, neurological, metabolic,haematological, gastrointestinal,endocrine or immunological diseases.
- Consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to dosing and during the study {one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit}.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- An unusual or abnormal diet e.g. low sodium diet, for two weeks prior to receiving any medication and through out subject's participation in the study, for whatever reason e.g. because of fasting due to religious reasons.
- Any major illness in the past three months or any clinically significant ongoing chronic medical illness e.g. congestive heart failure, hepatitis, pancreatitis etc.
- If any Dysplastic changes in the Papanicolaou Smear.
- Female volunteers demonstrating a positive pregnancy test.
- Female volunteers who are currently breast-feeding.
- History of problem in swallowing tablet.
- Used an oral contraceptive containing estrogens or progesterone, or any form of hormonal therapy or intake of HRT and pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 6 months of the start of the study.
- History of habituation to coffee, tea or other xanthine containing products and inability to withhold the intake during the-in house-stay.
About this study
Official title: An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative Oral Bioavailability Study Of Letrozole 2.5 mg Tablets (Test) Of Dr.Reddy's Laboratories Ltd And Femara 2.5 mg Tablets (Reference) Of Novartis Pharmaceuticals Corporation, USA In Healthy, Post Menopausal Women Subjects Under Fed Conditions
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fed conditions.
Read the detailed description
An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative oral bioavailability study in healthy, post menopausal women subjects under fed conditions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara® Tablets 2.5 mg
Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited
| Study group | Role | What they receive |
|---|---|---|
| Femara | Active comparator | Not described Receives: Drug: Letrozole |
| Letrozole | Experimental | Not described Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability based on Cmax and AUC parameters
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startApr 2008
- Primary completionJun 2008
- Study completionJun 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- A. Jaya Chandra Reddy, FRCS, Principal investigator, Trident Life Sciences Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372982
- Sponsor's protocol ID
- 033/08
- Status last verified
- Jun 2011
- First submitted
- 13 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative Oral Bioavailability Study Of Letrozole 2.5 mg Tablets (Test) Of Dr.Reddy's Laboratories Ltd And Femara 2.5 mg Tablets (Reference) Of Novartis Pharmaceuticals Corporation, USA In Healthy, Post Menopausal Women Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01372982
- Acronym / sponsor ID
- 033/08
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Jun 2011 (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 purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fed conditions.
Detailed description
An Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Cross-Over, Single-Dose, Comparative oral bioavailability study in healthy, post menopausal women subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femara | Active comparator | Drug: Letrozole |
| Letrozole | Experimental | Drug: Letrozole |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Healthy post menopausal women within the age range of 40 to 69 years.
- A body mass index within 18-29.9 Kg/m2
- The postmenopausal status should be confirmed by
- Serum Estradiol concentration < 40 pg/mL.
- Serum follicle stimulating hormone FSH)concentration >30 IU/L.
Key exclusion criteria (21 listed)
- Subjects incapable of understanding the informed consent.
- History of suggestive of breast carcinoma, endometrial carcinoma or cervical carcinoma.
- History of suggestive of deep vein thrombosis and / or undiagnosed vaginal bleeding.
- History of thromboembolic disorders.
- History of seizures.
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 |
|---|---|---|
| LetrozoleAlso: Femara® Tablets 2.5 mgLetrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited | Drug | Femara, Letrozole |
Primary outcome
Bioavailability based on Cmax and AUC parameters
Time frame: 3 Months
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 14 Jun 2011.
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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.
A. Jaya Chandra Reddy, FRCS principal investigator
Trident Life Sciences Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Letrozole in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 25 inclusion and 21 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 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Bioavailability based on Cmax and AUC parameters (time frame: 3 Months). 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 14 Jun 2011.