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Bioequivalence
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femara (Sequence 1) | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyeong-seok Lim, MD, PhD | Asan Medical Center | Principal Investigator |
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Study period: Jan 2009 ~ May 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Peratra First, Then Femara (Sequence 2) | Participants first received a generic letrozole (test - Peratra), then branded letrozole (reference - Femara). Each treatment period was separated by a 5-week washout period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Peratra First, Then Femara (Sequence 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ng•hr/mL | 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 |
|
10 Weeks (1) First Intervention : 2 Weeks (Blood samples were obtained before dosing and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 96, 168, and 312 hours after oral administration of 2.5 mg of letrozole) (2) Washout : 5 Weeks (3) Second Intervention : 2 Weeks (4) Last safety profile assessment : 1 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peratra | The group of participants who were administered Peratra. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Asan Medical Center | mdlhs@amc.seoul.kr |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| Peratra (Sequence 1) | Drug | 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 | 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 | 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. |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Letrozole : Cmax | Maximum Measured Concentration of Letrozole in Plasma | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
|
|
| 26 |
| 0 |
| 26 |
| 8 |
| 26 |
| EG001 | Femara | The group of participants who were administered Femara. | 0 | 26 | 0 | 26 | 4 | 26 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Asthenia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Ankle sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Non-systematic Assessment |
|
| Blood Triglyceride Increased | Investigations | Non-systematic Assessment |
|
| Creatine Kinase Increased | Investigations | Non-systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Investigations | Non-systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | Non-systematic Assessment |
|
| Blood Calcium Increased | Investigations | Non-systematic Assessment |
|
| Urinary Occult Blood Positive | Investigations | Non-systematic Assessment |
|
The results of the study shall be owned by the Sponsor. The results of this study can be published in journals with the consent of the Sponsor, and the Sponsor can also request the presentation of the results to the investigator(s).
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |