Trial Outcomes & Findings for Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets (NCT NCT00684723)
NCT ID: NCT00684723
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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the reference formulation, Mevacor® 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received one tablet of the test formulation, Lovastatin 40 mg, thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
|---|---|---|
|
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
|
27
|
27
|
|
First Intervention
STARTED
|
27
|
27
|
|
Washout Period of 7 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
27
|
27
|
|
Second Intervention
COMPLETED
|
27
|
27
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fed 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 thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
42 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 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.The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Lovastatin 40 mg Tablets
n=54 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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
Mevacor® 40 mg Tablets
n=54 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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
9.26 ng/mL
Standard Deviation 6.13
|
10.01 ng/mL
Standard Deviation 7.06
|
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.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=54 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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
Mevacor® 40 mg Tablets
n=54 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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
47.86 ng-hr/mL
Standard Deviation 29.34
|
51.64 ng-hr/mL
Standard Deviation 33.05
|
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.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=54 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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
Mevacor® 40 mg Tablets
n=54 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, thirty minutes after the start of a standardized high-fat, high-calorie breakfast. After a 7 day washout period, on the morning of Day 8, subjects received the alternate regimen thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
48.72 ng-hr/mL
Standard Deviation 29.14
|
52.98 ng-hr/mL
Standard Deviation 34.38
|
Adverse Events
Lovastatin 40 mg Tablets
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Mevacor® 40 mg Tablets
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lovastatin 40 mg Tablets
n=54 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 thirty minutes after the start of a standardized high-fat, high-calorie breakfast.
|
Mevacor® 40 mg Tablets
n=54 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 thirty minutes after the start of a standardized high-fat, high- calorie breakfast.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
1.9%
1/54 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/54 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Dry mouth
|
1.9%
1/54 • Number of events 1
|
0.00%
0/54
|
|
Gastrointestinal disorders
Dry throat
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/54
|
3.7%
2/54 • Number of events 2
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • Number of events 2
|
0.00%
0/54
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 1
|
0.00%
0/54
|
|
General disorders
Asthenia
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Catheter site edema
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Catheter site pain
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
General disorders
Catheter site related reaction
|
1.9%
1/54 • Number of events 1
|
0.00%
0/54
|
|
General disorders
Edema peripheral
|
1.9%
1/54 • Number of events 1
|
0.00%
0/54
|
|
General disorders
Venipuncture site bruise
|
3.7%
2/54 • Number of events 2
|
0.00%
0/54
|
|
General disorders
Venipuncture site swelling
|
1.9%
1/54 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burn esophageal
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
2/54 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/54 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
3.7%
2/54 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
|
Investigations
Eosinophil count increased
|
5.6%
3/54 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
|
Investigations
Lymphocyte count decreased
|
1.9%
1/54 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
|
Investigations
Neutrophil count increased
|
5.6%
3/54 • Number of events 3
|
5.6%
3/54 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/54
|
3.7%
2/54 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
1.9%
1/54 • Number of events 1
|
5.6%
3/54 • Number of events 3
|
|
Nervous system disorders
Headache
|
9.3%
5/54 • Number of events 5
|
5.6%
3/54 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
16.7%
9/54 • Number of events 9
|
9.3%
5/54 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
Vascular disorders
Epistaxis
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
|
Vascular disorders
Pallor
|
0.00%
0/54
|
1.9%
1/54 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60