Trial Outcomes & Findings for Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets (NCT NCT00685685)
NCT ID: NCT00685685
Last Updated: 2010-01-20
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.
Results posted on
2010-01-20
Participant Flow
Participant milestones
| Measure |
Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours.
|
Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, Mevacor® 40 mg after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
First Intervention
STARTED
|
27
|
27
|
|
First Intervention
COMPLETED
|
27
|
27
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
27
|
27
|
|
Washout Period of 7 Days
COMPLETED
|
25
|
26
|
|
Washout Period of 7 Days
NOT COMPLETED
|
2
|
1
|
|
Second Intervention
STARTED
|
25
|
26
|
|
Second Intervention
COMPLETED
|
25
|
26
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets
On the morning of Day 1 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours.
|
Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets
On the morning of Day 1 subjects received one tablet of the reference formulation, Mevacor® 40 mg after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, Lovastatin 40 mg, after an overnight fast of at least 10 hours.
|
|---|---|---|
|
Washout Period of 7 Days
Adverse Event
|
2
|
0
|
|
Washout Period of 7 Days
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
Baseline characteristics by cohort
| Measure |
Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets
n=54 Participants
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age Continuous
|
40.4 years
STANDARD_DEVIATION 12.57 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.Population: Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Lovastatin 40 mg Tablets
n=51 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
Mevacor® 40 mg Tablets
n=51 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
1.86 ng/mL
Standard Deviation 1.05
|
1.96 ng/mL
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.Population: Plasma concentration data for 51 of the 54 enrolled subjects were used in the statistical analysis. Two subjects were withdrawn from the study for adverse reactions and one subject withdrew his consent for personal reasons.
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
Outcome measures
| Measure |
Lovastatin 40 mg Tablets
n=51 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
Mevacor® 40 mg Tablets
n=51 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
30.64 ng-hr/mL
Standard Deviation 15.79
|
30.36 ng-hr/mL
Standard Deviation 17.28
|
PRIMARY outcome
Timeframe: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 10, 14, 18, 24, 36, and 48 hours after drug administration.Population: 54 subjects were enrolled and 51 subjects completed the study. Lovastatin plasma concentration data for 48 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 3 subjects. Mevacor® plasma concentration data for 50 subjects were used in the statistical analysis as the AUC(0-∞) was not calculated for 1 subject.
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Outcome measures
| Measure |
Lovastatin 40 mg Tablets
n=48 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
Mevacor® 40 mg Tablets
n=50 Participants
On the morning of Day 1 subjects received one tablet of either the test formulation, Lovastatin 40 mg, or the reference formulation, Mevacor® 40 mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. On the morning of Day 8 subjects received the alternate regimen following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
34.52 ng-hr/mL
Standard Deviation 17.50
|
33.80 ng-hr/mL
Standard Deviation 18.97
|
Adverse Events
Lovastatin 40 mg Tablets
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Mevacor® 40 mg Tablets
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lovastatin 40 mg Tablets
n=53 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
|
Mevacor® 40 mg Tablets
n=52 participants at risk
All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either Lovastatin 40 mg or Mevacor® 40 mg following an overnight fast of at least 10 hours.
|
|---|---|---|
|
Gastrointestinal disorders
loose stools
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
1.9%
1/52 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Investigations
blood creatine phosphokinase increased
|
3.8%
2/53 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
5.8%
3/52 • Number of events 3
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Investigations
blood urea increased
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
1.9%
1/52 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Investigations
heart rate decreased
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
0.00%
0/52
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Investigations
neutrophil count decreased
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
1.9%
1/52 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.8%
2/53 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
0.00%
0/52
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Nervous system disorders
dizziness
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
1.9%
1/52 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Nervous system disorders
headache
|
3.8%
2/53 • Number of events 2
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
1.9%
1/52 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Nervous system disorders
somnolence
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
0.00%
0/52
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Skin and subcutaneous tissue disorders
erythema
|
0.00%
0/53
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
1.9%
1/52 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Skin and subcutaneous tissue disorders
rash papular
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
0.00%
0/52
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Skin and subcutaneous tissue disorders
sweating increased
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
0.00%
0/52
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
|
Vascular disorders
pallor
|
1.9%
1/53 • Number of events 1
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
0.00%
0/52
54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving both interventions. 53 subjects were administered lovastatin 40 mg tablest and 52 subjects were administered Mevacor® 40 mg tablets.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60