HealthyPhase 1NCT00685685
Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
A Phase 1 study testing Lovastatin 40 mg tablets and Lovastatin (Mevacor®) 40 mg Tablets in people with Healthy, run by Mutual Pharmaceutical Company, Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lovastatin 40 mg tablets and Lovastatin (Mevacor®) 40 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Oct 2004
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly signed by the volunteer
- Male aged of at least 18 with a body mass index (BMI) greater than or equal to 19 and below 30 kg/m²
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
- Healthy according to the laboratory results and physical examination
- Light, non- or ex-smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex-smokers are defined as someone who completely stopped smoking for at least 3 months
- The informed consent form must be signed by all volunteers, prior to their participation in the study
Who cannot join
- Significant history of hypersensitivity to lovastatin or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
- Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of active liver disease or unexplained persistent elevations of serum transaminases
- Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (>3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
Show all 12Show fewer
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)
- Participation in another clinical trial in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
- Positive urine screening of drugs of abuse
- Positive results to HIV, HBsAg or anti-HCV tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose Crossover Comparative Bioavailability Study of Lovastatin 40mg Tablets in Healthy Male Volunteers/Fasting State
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Lovastatin 40 mg tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Keywords
- Therapeutic Equivalency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lovastatin 40 mg tabletsDrug
40 mg tablet administered after an overnight fast of at least 10 hours
Lovastatin (Mevacor®) 40 mg TabletsDrug
Also called Mevacor®
40 mg tablet administered after an overnight fast of at least 10 hours
| Study group | Role | What they receive |
|---|---|---|
| Lovastatin 40 mg tablet | Experimental | A single dose of Lovastatin 40 mg administered after an overnight fast of at least 10 hours. Receives: Drug: Lovastatin 40 mg tablets |
| Lovastatin (Mevacor®) 40 mg Tablet | Experimental | A single dose of Lovastatin (Mevacor®) 40 mg administered after an overnight fast of at least 10 hours. Receives: Drug: Lovastatin (Mevacor®) 40 mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startSep 2004
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685685
- Sponsor's protocol ID
- LVI-P4-125
- Status last verified
- Jan 2010
- First submitted
- 24 May 2008
- Last updated
- 20 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Crossover Comparative Bioavailability Study of Lovastatin 40mg Tablets in Healthy Male Volunteers/Fasting State
- ClinicalTrials.gov ID
- NCT00685685
- Acronym / sponsor ID
- LVI-P4-125
- Conditions
- Healthy
- Keywords
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Posted 30 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lovastatin 40 mg tablet | Experimental | Drug: Lovastatin 40 mg tabletsA single dose of Lovastatin 40 mg administered after an overnight fast of at least 10 hours. |
| Lovastatin (Mevacor®) 40 mg Tablet | Experimental | Drug: Lovastatin (Mevacor®) 40 mg TabletsA single dose of Lovastatin (Mevacor®) 40 mg administered after an overnight fast of at least 10 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly signed by the volunteer
- Male aged of at least 18 with a body mass index (BMI) greater than or equal to 19 and below 30 kg/m²
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
- Healthy according to the laboratory results and physical examination
- Light, non- or ex-smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex-smokers are defined as someone who completely stopped smoking for at least 3 months
Key exclusion criteria (12 listed)
- Significant history of hypersensitivity to lovastatin or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
- Presence of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of active liver disease or unexplained persistent elevations of serum transaminases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lovastatin 40 mg tablets40 mg tablet administered after an overnight fast of at least 10 hours | Drug | Lovastatin 40 mg tablet |
| Lovastatin (Mevacor®) 40 mg TabletsAlso: Mevacor®40 mg tablet administered after an overnight fast of at least 10 hours | Drug | Lovastatin (Mevacor®) 40 mg Tablet |
Primary outcome
Maximum Plasma Concentration (Cmax)
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.
The maximum or peak concentration that the drug reaches in the plasma.
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
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.
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.
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
- Daily Med - Posting of Recently Submitted Labeling to the FDALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lovastatin 40 mg tablets and Lovastatin (Mevacor®) 40 mg Tablets in people with Healthy, run by Mutual Pharmaceutical Company, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2010.