HealthyPhase 1NCT01146106
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fasting Conditions
A Phase 1 study testing Pravastatin Sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pravastatin Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Dec 2002
- 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
- Healthy males and females at least 18 years of age.
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and ll).
Who cannot join
- Hypersensitivity to Pravastatin (pravachol®), or similar compounds.
- Any history ofa clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
- Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
- If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IDD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
About this study
Official title: Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets in Healthy Volunteers
This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.
Read the detailed description
Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.
A total of 43 non-smoking subjects (31 men and 12 women) were included in this study, of which 43 finished the study according to the protocol.The study was performed as a single-dose two-way (80 mg), crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test
- Conditions
- Healthy
- Being tested
- Pravastatin Sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin SodiumDrug
Also called Pravachol 80 mg tablets
Pravastatin Sodium Tablets 80 mg
| Study group | Role | What they receive |
|---|---|---|
| Pravastatin Sodium Tablets 80 mg | Experimental | Dr.Reddy's Laboratories Limited Receives: Drug: Pravastatin Sodium |
| Pravachol 80 mg Tablets | Active comparator | Bristol Myers Squibb Receives: Drug: Pravastatin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startDec 2002
- Primary completionDec 2002
- Study completionDec 2002
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ralph Scallion EE, MD, Principal investigator, AAI, 6101 Quadrangle Drive, Chapel Hill, NC 27514
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146106
- Sponsor's protocol ID
- AAI-US-139
- Status last verified
- Jun 2010
- First submitted
- 10 Feb 2010
- Last updated
- 17 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01146106
- Acronym / sponsor ID
- AAI-US-139
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 17 Jun 2010 (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.
This is a single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80 mg, Bristol Myers Squibb in Healthy Volunteers.
Detailed description
Single Dose Two-Way Crossover Fasting Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.
A total of 43 non-smoking subjects (31 men and 12 women) were included in this study, of which 43 finished the study according to the protocol.The study was performed as a single-dose two-way (80 mg), crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pravastatin Sodium Tablets 80 mg | Experimental | Drug: Pravastatin SodiumDr.Reddy's Laboratories Limited |
| Pravachol 80 mg Tablets | Active comparator | Drug: Pravastatin SodiumBristol Myers Squibb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and females at least 18 years of age.
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs. (Appendix I and ll).
Key exclusion criteria (8 listed)
- Hypersensitivity to Pravastatin (pravachol®), or similar compounds.
- Any history ofa clinical condition which might affect drug absorption, metabolism or excretion.
- Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood
- Received an investigational drug within the 4 weeks prior to study dosing.
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 |
|---|---|---|
| Pravastatin SodiumAlso: Pravachol 80 mg tabletsPravastatin Sodium Tablets 80 mg | Drug | Pravachol 80 mg Tablets, Pravastatin Sodium Tablets 80 mg |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 1 month
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 17 Jun 2010.
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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.
Ralph Scallion EE, MD principal investigator
AAI, 6101 Quadrangle Drive, Chapel Hill, NC 27514
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pravastatin Sodium in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 3 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 17 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
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 based on Cmax and AUC parameters (time frame: 1 month). 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 17 Jun 2010.