A Phase 1 interventional study of Lovastatin 40 mg tablets and Lovastatin (Mevacor®) 40 mg Tablets in Healthy, sponsored by Mutual Pharmaceutical Company, Inc.. Completed at 1 site in Canada. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-20.
Sponsored by Mutual Pharmaceutical Company, Inc. · Phase 1 and Interventional
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions.
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose administered under fasting conditions.
Fifty-four healthy, light/non/or ex-smoking, non-obese, male volunteers at least 18 years of age will be randomly assigned in a crossover fashion to receive each of two lovastatin dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, lovastatin (1 x 40 mg tablet), or a single oral dose of the reference formulation, Mevacor® (1 x 40 mg tablet). After a 7 day washout period on the morning of Day 8, following an overnight fast of at least 10 hours, subjects will receive the alternate regimen. Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of lovastatin. Blood sampling will then continue on a non-confined basis at 36 and 48 hours post-dose. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. Vital signs will be monitored if judged necessary by the physician in charge. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.
Mutual Pharmaceutical Company, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
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Exclusion Criteria:
A single dose of Lovastatin 40 mg administered after an overnight fast of at least 10 hours.
Drug: Lovastatin 40 mg tablets
A single dose of Lovastatin (Mevacor®) 40 mg administered after an overnight fast of at least 10 hours.
Drug: Lovastatin (Mevacor®) 40 mg Tablets
40 mg tablet administered after an overnight fast of at least 10 hours
40 mg tablet administered after an overnight fast of at least 10 hours
Also known as: Mevacor®
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma.
Time frame: 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.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
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.
Time frame: 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.
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
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.
Time frame: 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.
| Milestone | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets |
|---|---|---|
| Started | 27 | 27 |
| Completed | 27 | 27 |
| Not completed | 0 | 0 |
| Milestone | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets |
|---|---|---|
| Started | 27 | 27 |
| Completed | 25 | 26 |
| Not completed | 2 | 1 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Lovastatin 40 mg Tablets Then Mevacor® 40 mg Tablets | Mevacor® 40 mg Tablets Then Lovastatin 40 mg Tablets |
|---|---|---|
| Started | 25 | 26 |
| Completed | 25 | 26 |
| Not completed | 0 | 0 |
The maximum or peak concentration that the drug reaches in the plasma.
| ng/mL | Lovastatin 40 mg Tablets | Mevacor® 40 mg Tablets |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 1.86 ± 1.05 | 1.96 ± 1.02 |
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.
| ng-hr/mL | Lovastatin 40 mg Tablets | Mevacor® 40 mg Tablets |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] | 30.64 ± 15.79 | 30.36 ± 17.28 |
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.
| ng-hr/mL | Lovastatin 40 mg Tablets | Mevacor® 40 mg Tablets |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] | 34.52 ± 17.50 | 33.80 ± 18.97 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lovastatin 40 mg Tablets | — | 0/53 (0%) | 10/53 (18.9%) |
| Mevacor® 40 mg Tablets | — | 0/52 (0%) | 7/52 (13.5%) |
| Event | Lovastatin 40 mg Tablets | Mevacor® 40 mg Tablets |
|---|---|---|
| blood creatine phosphokinase increasedInvestigations | 2/53 | 3/52 |
| back painMusculoskeletal and connective tissue disorders | 2/53 | 0/52 |
| headacheNervous system disorders | 2/53 | 1/52 |
| loose stoolsGastrointestinal disorders | 0/53 | 1/52 |
| blood urea increasedInvestigations | 1/53 | 1/52 |
| neutrophil count decreasedInvestigations | 1/53 | 1/52 |
| dizzinessNervous system disorders | 1/53 | 1/52 |
| erythemaSkin and subcutaneous tissue disorders | 0/53 | 1/52 |
| heart rate decreasedInvestigations | 1/53 | 0/52 |
| somnolenceNervous system disorders | 1/53 | 0/52 |
| Age, Categorical(Participants) | Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 53 |
| >=65 years | 1 |
| Age Continuous(years) | Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets |
|---|---|
| Mean | 40.4 ± 12.57 |
| Sex: Female, Male(Participants) | Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets |
|---|---|
| Female | 0 |
| Male | 54 |
| Race (NIH/OMB)(Participants) | Lovastatin 40 mg Tablets and Mevacor® 40 mg Tablets |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 52 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Mutual Pharmaceutical Company, Inc.