Healthy
Conditions
Keywords
Healthy Subjects
Brief summary
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.
Interventions
DRUGFemara (Sequence 1)
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.
DRUGPeratra (Sequence 1)
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.
DRUGFemara (Sequence 2)
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.
DRUGPeratra (Sequence 2)
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.
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Letrozole : AUC0-tz | 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 | 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 |
Participant flow
Recruitment details
Study period: Jan 2009 \ May 2009
Participants by arm
| Arm | Count |
|---|---|
| Femara First, Then Peratra (Sequence 1) Participants first received a branded letrozole (reference - Femara), then a generic letrozole (test - Peratra). Each treatment period was separated by a 5-week washout period. | 13 |
| Peratra First, Then Femara (Sequence 2) Participants first received a generic letrozole (test - Peratra), then a branded letrozole (reference - Femara). Each treatment period was separated by a 5-week washout period. | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Femara First, Then Peratra (Sequence 1) | Peratra First, Then Femara (Sequence 2) | Total |
|---|---|---|---|
| Age, Customized Age | 28.8 years STANDARD_DEVIATION 4.8 | 27.5 years STANDARD_DEVIATION 4.1 | 28.1 years STANDARD_DEVIATION 4.4 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 8 / 26 | 4 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
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.
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peratra | Letrozole : AUC0-tz | 2074.71 ng•hr/mL | Standard Deviation 826.15 |
| Femara | Letrozole : AUC0-tz | 2094.63 ng•hr/mL | Standard Deviation 870.79 |
Primary
Letrozole : Cmax
Maximum Measured Concentration of Letrozole in Plasma
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peratra | Letrozole : Cmax | 35.38 ng/mL | Standard Deviation 6.66 |
| Femara | Letrozole : Cmax | 38.13 ng/mL | Standard Deviation 7.03 |