Trial Outcomes & Findings for Bioequivalence Study of Letrozole 2.5 mg Tablets (NCT NCT01084499)
NCT ID: NCT01084499
Last Updated: 2019-03-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
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
Results posted on
2019-03-29
Participant Flow
Study period: Jan 2009 \~ May 2009
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
Washout (5 Weeks)
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Letrozole 2.5 mg Tablets
Baseline characteristics by cohort
| Measure |
Femara First, Then Peratra (Sequence 1)
n=13 Participants
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.
|
Peratra First, Then Femara (Sequence 2)
n=13 Participants
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.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
28.8 years
STANDARD_DEVIATION 4.8 • n=113 Participants
|
27.5 years
STANDARD_DEVIATION 4.1 • n=163 Participants
|
28.1 years
STANDARD_DEVIATION 4.4 • n=160 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=113 Participants
|
13 Participants
n=163 Participants
|
26 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 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 administrationArea Under the Concentration-time Curve of Letrozole in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point.
Outcome measures
| Measure |
Peratra
n=26 Participants
The group of participants who were administered Peratra.
|
Femara
n=26 Participants
The group of participants who were administered Femara.
|
|---|---|---|
|
Letrozole : AUC0-tz
|
2074.71 ng•hr/mL
Standard Deviation 826.15
|
2094.63 ng•hr/mL
Standard Deviation 870.79
|
PRIMARY outcome
Timeframe: 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 administrationMaximum Measured Concentration of Letrozole in Plasma
Outcome measures
| Measure |
Peratra
n=26 Participants
The group of participants who were administered Peratra.
|
Femara
n=26 Participants
The group of participants who were administered Femara.
|
|---|---|---|
|
Letrozole : Cmax
|
35.38 ng/mL
Standard Deviation 6.66
|
38.13 ng/mL
Standard Deviation 7.03
|
Adverse Events
Peratra
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Femara
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Peratra
n=26 participants at risk
The group of participants who were administered Peratra.
|
Femara
n=26 participants at risk
The group of participants who were administered Femara.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Discomfort
|
7.7%
2/26 • Number of events 2 • 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
|
0.00%
0/26 • 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
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/26 • 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
|
3.8%
1/26 • Number of events 1 • 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
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/26 • 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
|
7.7%
2/26 • Number of events 2 • 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
|
|
Nervous system disorders
Asthenia
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Nervous system disorders
Headache
|
0.00%
0/26 • 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
|
3.8%
1/26 • Number of events 1 • 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
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Investigations
Blood Bilirubin Increased
|
3.8%
1/26 • Number of events 1 • 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
|
3.8%
1/26 • Number of events 1 • 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
|
|
Investigations
Blood Triglyceride Increased
|
3.8%
1/26 • Number of events 1 • 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
|
3.8%
1/26 • Number of events 1 • 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
|
|
Investigations
Creatine Kinase Increased
|
3.8%
1/26 • Number of events 1 • 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
|
3.8%
1/26 • Number of events 1 • 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
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Investigations
Alanine Aminotransferase Increased
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Investigations
Blood Calcium Increased
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
|
Investigations
Urinary Occult Blood Positive
|
3.8%
1/26 • Number of events 1 • 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
|
0.00%
0/26 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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).
- Publication restrictions are in place
Restriction type: OTHER