HealthyPhase 1NCT00834847
Pravastatin Sodium 40 mg Tablets Food Challenge Study
A Phase 1 study testing pravastatin and Pravachol® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial summary
The objective of this study is to compare the relative bioavailability of pravastatin 40 mg tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting conditions. A second objective is to compare the difference in plasma levels after dosing the test formulation with and without food. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- pravastatin and Pravachol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2000to Sep 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-institutionalized subjects consisting of university students and members of the community at large.
- All subjects selected for this study will be males 18 to 45 (inclusive) years of age. Weight of the subjects shall not be more than 15% from the normal for height and body frame (Metropolitan Life, 1993, Height, Weight, Body Chart).
- Each subject shall be given a general physical examination within 21 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
- At the end of the study the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
- Adequate blood and urine samples should be obtained within 21 days before the beginning of the first period and at the end of the trial for clinical laboratory measurements.
- Clinical laboratory measurements will include the following:
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- Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential)
- Clinical Chemistry: creatinine, BUN, glucose, SGOT, SGPT, bilirubin, and alkaline phosphatase
- Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells
- HIV Screen: (pre-study only)
- Hepatitis-B, C Screen: (pre-study only)
- Drugs of Abuse Screen: (pre-study and at each dosing period check-in)
- Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.
Who cannot join
- Subjects with a history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
- Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
- Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
- All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
- Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
- Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
- Subjects who have been exposed to known hepatic enzyme inducing or inhibiting agents within (30) days prior to dosing will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Food Challenge Study of Pravastatin Sodium 40 mg Tablets
The objective of this study is to compare the relative bioavailability of pravastatin 40 mg tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting conditions. A second objective is to compare the difference in plasma levels after dosing the test formulation with and without food.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- pravastatin, Pravachol®
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pravastatinDrug
40 mg tablet
Pravachol®Drug
40 mg Tablet
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin fast | Experimental | Test product under fasting conditions dosed in first period followed by either test or reference product dosed under fed conditions in second and third periods Receives: Drug: pravastatin |
| Pravastatin | Experimental | Test product under fed conditions dosed in first period followed by either test product dosed under fasting conditions or reference product dosed under fed conditions in second and third periods Receives: Drug: pravastatin |
| Pravachol® | Active comparator | Reference product under fed conditions dosed in first period followed by test product dosed under either fed or fasted conditions in second and third periods Receives: Drug: Pravachol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration
Measured: Blood samples collected over 24 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Measured: Blood samples collected over 24 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
Measured: Blood samples collected over 24 hour period
Secondary outcomes (3)
Cmax - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Measured: Blood samples collected over 24 hour period
AUC0-inf - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Measured: Blood samples collected over 24 hour period
AUC0-t - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Measured: Blood samples collected over 24 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startAug 2000
- Primary completionSep 2000
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dan Yeung, MD, Principal investigator, Pharma Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834847
- Sponsor's protocol ID
- B006512
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2009
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Food Challenge Study of Pravastatin Sodium 40 mg Tablets
- ClinicalTrials.gov ID
- NCT00834847
- Acronym / sponsor ID
- B006512
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Sep 2000 (actual)
- Study completion
- Sep 2000 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare the relative bioavailability of pravastatin 40 mg tablets with that of Pravachol 40 mg tablets in healthy adult male subjects under non-fasting conditions. A second objective is to compare the difference in plasma levels after dosing the test formulation with and without food.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pravastatin fast | Experimental | Drug: pravastatinTest product under fasting conditions dosed in first period followed by either test or reference product dosed under fed conditions in second and third periods |
| Pravastatin | Experimental | Drug: pravastatinTest product under fed conditions dosed in first period followed by either test product dosed under fasting conditions or reference product dosed under fed conditions in second and third periods |
| Pravachol® | Active comparator | Drug: Pravachol®Reference product under fed conditions dosed in first period followed by test product dosed under either fed or fasted conditions in second and third periods |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Non-institutionalized subjects consisting of university students and members of the community at large.
- All subjects selected for this study will be males 18 to 45 (inclusive) years of age. Weight of the subjects shall not be more than 15% from the normal for height and body frame (Metropolitan Life, 1993, Height, Weight, Body Chart).
- Each subject shall be given a general physical examination within 21 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
- At the end of the study the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
- Adequate blood and urine samples should be obtained within 21 days before the beginning of the first period and at the end of the trial for clinical laboratory measurements.
Key exclusion criteria (8 listed)
- Subjects with a history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
- Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
- Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
- All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
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 |
|---|---|---|
| pravastatin40 mg tablet | Drug | Pravastatin, Pravastatin fast |
| Pravachol®40 mg Tablet | Drug | Pravachol® |
Primary outcome
Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 24 hour period
AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Time frame: Blood samples collected over 24 hour period
AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (per participant)
Time frame: Blood samples collected over 24 hour period
3 secondary outcomes
Cmax - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Time frame: Blood samples collected over 24 hour period
AUC0-inf - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Time frame: Blood samples collected over 24 hour period
AUC0-t - Comparison of the difference in plasma levels after dosing with test product under fasted and fed conditions
Time frame: Blood samples collected over 24 hour period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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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.
Dan Yeung, MD principal investigator
Pharma Medica
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 pravastatin and Pravachol® in people with Healthy, run by Teva Pharmaceuticals USA 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 13 inclusion and 8 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 9 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax - Maximum Observed Concentration (time frame: Blood samples collected over 24 hour period). 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 9 Jan 2020.