HealthyNCT01084499
Bioequivalence Study of Letrozole 2.5 mg Tablets
A study testing Femara (Sequence 1), Peratra (Sequence 1) and Femara (Sequence 2) in people with Healthy, run by Yuhan Corporation.
Trial summary
Bioequivalence Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Femara (Sequence 1), Peratra (Sequence 1) and Femara (Sequence 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to May 2009
- Phase
- Interventional
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers in the age between 19 to 55 years old
- Subjects were neither congenital nor chronic diseases.
- Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
Who cannot join
- Any history of a clinical condition which might affect drug absorption, distribution, metabolism or excretion or might be risk factors, e.g. clinically significant disorder in heart, liver, respiratory system, liver, kidney, gastrointestinal system and CNS
- Had a history of myocardial infarction, stroke, hypertension, arrhythmia, coronary artery disease, disease of neuropsychiatry, gastrointestinal system surgery (excluding appendectomy, herniotomy)
- Current clinically significant disorder in history taking or physical examination
- Acute disease within 14 days preceding the first application of study medication
- Had an relevant allergic disease
- Had history of hypersensitivity to drugs or any food
Show all 14Show fewer
- Positive for Hepatitis B antigen, Hepatitis C antibody, HIV antibody, or High Quality Syphilis Reagin Test
- Excessive caffeine, alcohol intake and smoker(caffeine>5 units/day, alcohol>3 units/day(1 unit = pure alcohol 10ml), cigarettes> 20 cigarettes /day)
- Subjects who excessive alcohol intake or drug which affect drug metabolism enzyme intake within 30 days preceding study
- History of drug abuse or positive for urinary testing of drugs abuse (amphetamine, barbiturates, cocaine, opioids, benzodiazepines etc.)
- Has donated whole blood within 60days or apheresis within 14days preceding the first application of study medication
- Received other investigational drug within 60days preceding the first application of study medication
- Taken any herbal medicine within 30days, prescription medication within 14 days or over-the-counter drug (except for vitamins, minerals) within 10days preceding the first application of study medication (might affect this study or safety of subjects as judged by the investigator)
- Subjects couldn't eat ASAN MEDICAL CENTER standard meal or were unsuitable for this study as judged by investigators
About this study
Official title: Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets
Bioequivalence
Read the detailed description
The purpose of this study was to determine the bioequivalence of letrozole 2.5 mg tablets after administration of single doses to normal healthy Korean subjects under fasted conditions.
- Conditions
- Healthy
- Being tested
- Femara (Sequence 1), Peratra (Sequence 1), Femara (Sequence 2), Peratra (Sequence 2)
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femara (Sequence 1)Drug
Also called Femara Tab.[Letrozole 2.5mg]
Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.
Peratra (Sequence 1)Drug
Also called Peratra Tab.[Letrozole 2.5mg]
Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.
Femara (Sequence 2)Drug
Also called Femara Tab.[Letrozole 2.5mg]
Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.
Peratra (Sequence 2)Drug
Also called Peratra Tab.[Letrozole 2.5mg]
Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.
| Study group | Role | What they receive |
|---|---|---|
| Femara First, Then Peratra (Sequence 1) | Experimental | Participants first receives a branded letrozole (reference - Femara), then a generic letrozole (test - Peratra). Each treatment period is separated by a 5-week washout period. Receives: Drug: Femara (Sequence 1); Drug: Peratra (Sequence 1) |
| Peratra First, Then Femara (Sequence 2) | Experimental | Participants first receives a generic letrozole (test - Peratra) , then a branded letrozole (reference - Femara). Each treatment period is separated by a 5-week washout period. Receives: Drug: Femara (Sequence 2); Drug: Peratra (Sequence 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Letrozole : AUC0-tz
Area Under the Concentration-time Curve of Letrozole in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point.
Measured: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration
Letrozole : Cmax
Maximum Measured Concentration of Letrozole in Plasma
Measured: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionMay 2009
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 HealthyStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyeong-seok Lim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084499
- Sponsor's protocol ID
- YCD143
- Status last verified
- Mar 2019
- First submitted
- 9 Mar 2010
- Last updated
- 29 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of YUHAN Letrozole 2.5 mg Tablets
- ClinicalTrials.gov ID
- NCT01084499
- Acronym / sponsor ID
- YCD143
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 29 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bioequivalence
Detailed description
The purpose of this study was to determine the bioequivalence of letrozole 2.5 mg tablets after administration of single doses to normal healthy Korean subjects under fasted conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femara First, Then Peratra (Sequence 1) | Experimental | Drug: Femara (Sequence 1), Drug: Peratra (Sequence 1)Participants first receives a branded letrozole (reference - Femara), then a generic letrozole (test - Peratra). Each treatment period is separated by a 5-week washout period. |
| Peratra First, Then Femara (Sequence 2) | Experimental | Drug: Femara (Sequence 2), Drug: Peratra (Sequence 2)Participants first receives a generic letrozole (test - Peratra) , then a branded letrozole (reference - Femara). Each treatment period is separated by a 5-week washout period. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male volunteers in the age between 19 to 55 years old
- Subjects were neither congenital nor chronic diseases.
- Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
Key exclusion criteria (14 listed)
- Any history of a clinical condition which might affect drug absorption, distribution, metabolism or excretion or might be risk factors, e.g. clinically significant disorder in heart, liver, respiratory system, liver, kidney, gastrointestinal system and CNS
- Had a history of myocardial infarction, stroke, hypertension, arrhythmia, coronary artery disease, disease of neuropsychiatry, gastrointestinal system surgery (excluding appendectomy, herniotomy)
- Current clinically significant disorder in history taking or physical examination
- Acute disease within 14 days preceding the first application of study medication
- Had an relevant allergic disease
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 |
|---|---|---|
| Femara (Sequence 1)Also: Femara Tab.[Letrozole 2.5mg]Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period. | Drug | Femara First, Then Peratra (Sequence 1) |
| Peratra (Sequence 1)Also: Peratra Tab.[Letrozole 2.5mg]Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period. | Drug | Femara First, Then Peratra (Sequence 1) |
| Femara (Sequence 2)Also: Femara Tab.[Letrozole 2.5mg]Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period. | Drug | Peratra First, Then Femara (Sequence 2) |
| Peratra (Sequence 2)Also: Peratra Tab.[Letrozole 2.5mg]Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period. | Drug | Peratra First, Then Femara (Sequence 2) |
Primary outcome
Letrozole : AUC0-tz
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration
Area Under the Concentration-time Curve of Letrozole in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point.
Letrozole : Cmax
Time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration
Maximum Measured Concentration of Letrozole in Plasma
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- 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.
Hyeong-seok Lim, MD, PhD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Femara (Sequence 1), Peratra (Sequence 1) and Femara (Sequence 2) in people with Healthy, run by Yuhan Corporation.
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 4 inclusion and 14 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 29 Mar 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2019). 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?
Letrozole : AUC0-tz (time frame: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, 312 hrs after drug administration). The study lists 2 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 29 Mar 2019.