Therapeutic EquivalencyPhase 1NCT00650221
Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects
A Phase 1 study testing Pravastatin in people with Therapeutic Equivalency, run by Mylan Pharmaceuticals Inc at 1 site in Canada.
Trial summary
The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- Pravastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Jul 2003
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects meeting the following criteria may be included in the study:
- Non-smoking male or female with a minimum age of 18 years.
- Body Mass Index (BMI = weight/height2) greater than or equal to 19 kg/m2 and less than or equal to 26 kg/m2.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
- Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min and temperature between 35.8°C and 37.5°C).
- Negative for drugs of abuse, nicotine , alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).
- No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
- Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.
Who cannot join
- Subjects meeting any of the following criteria will be excluded:
- Known history of hypersensitivity to pravastatin sodium (e.g. Pravachol®, Lipostat®) and/or related drugs such as simvastatin (Zocor®), atorvastatin (Lipitor™), cerivastatin (Baycol®) or fluvastatin (Lescol®).
- Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
- Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness during the last four weeks prior to entry into this study.
- Presence of any significant physical or organ abnormality.
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- Any subject with a history of drug abuse.
- Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
- Use of any prescription medication within 14 days preceding entry into this study.
- Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
- Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
- Female subjects: presence of pregnancy or lactation.
- Any subject who has had blood withdrawals within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
- Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- Any subject who has donated blood within 56 days preceding this study.
- Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
- Significant or recent history of asthma (after 12 years of age).
- Any subject with a recent (less than one year) history of alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects
The objective of this study was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions.
Based on the results from this study, the two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fasting conditions.
- Conditions
- Therapeutic Equivalency
- Being tested
- Pravastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
Single-dose 80 mg immediate-release oral tablet
PravastatinDrug
Also called Pravachol®
Single-dose 80 mg immediate-release tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Pravastatin |
| 2 | Active comparator | Not described Receives: Drug: Pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJun 2003
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genpharm ULC
- Investigators
- Paul Tam, MD, Principal investigator, Biovail Contract Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650221
- Sponsor's protocol ID
- 2721
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2008
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Non-Smoking Male and Female Subjects
- ClinicalTrials.gov ID
- NCT00650221
- Acronym / sponsor ID
- 2721
- Conditions
- Therapeutic Equivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- Genpharm ULC
- Study start
- Jun 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 1 Apr 2008 (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 was to compare the rate and extent of absorption of pravastatin sodium from a test formulation of Pravastatin Sodium 80 mg Tablets versus the reference Pravachol® 80 mg Tablets under fasting conditions.
Based on the results from this study, the two 80 mg pravastatin tablet formulations demonstrated bioequivalence under the single-dose fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pravastatin |
| 2 | Active comparator | Drug: Pravastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects meeting the following criteria may be included in the study:
- Non-smoking male or female with a minimum age of 18 years.
- Body Mass Index (BMI = weight/height2) greater than or equal to 19 kg/m2 and less than or equal to 26 kg/m2.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
- Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min and temperature between 35.8°C and 37.5°C).
Key exclusion criteria (18 listed)
- Subjects meeting any of the following criteria will be excluded:
- Known history of hypersensitivity to pravastatin sodium (e.g. Pravachol®, Lipostat®) and/or related drugs such as simvastatin (Zocor®), atorvastatin (Lipitor™), cerivastatin (Baycol®) or fluvastatin (Lescol®).
- Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator, or medical designate.
- Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness during the last four weeks prior to entry into this study.
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 |
|---|---|---|
| PravastatinSingle-dose 80 mg immediate-release oral tablet | Drug | 1 |
| PravastatinAlso: Pravachol®Single-dose 80 mg immediate-release tablet | Drug | 2 |
Primary outcome
Bioequivalence
Time frame: Within 30 days
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 24 Apr 2024.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink 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.
Paul Tam, MD principal investigator
Biovail Contract Research
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 in people with Therapeutic Equivalency, run by Mylan Pharmaceuticals 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 8 inclusion and 18 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 24 Apr 2024. 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?
Bioequivalence (time frame: Within 30 days). 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 24 Apr 2024.