HealthyPhase 1NCT01645384
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg Under Fasting Conditions
A Phase 1 study testing Atorvastatin Calcium Tablets, 40 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atorvastatin Calcium Tablets, 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteIndia
- Study dates
- May 2009to Jul 2009
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- He/She should provide written informed consent.
- He/She must be a healthy adult within 18-45 years of age (inclusive).
- He/She should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- He/She should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg. Similarly diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
- He/She must be of normal health as determined by medical history and physical examination performed within 21 days prior to the dosing of period 1.
- He/She should have a normal ECG, chest X-ray and vital signs.
- Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence. or is postmenopausal for at least 1 year. or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study volunteers)
Who cannot join
- He/She is incapable of understanding the informed consent.
- He/She has a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- He/She has any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy,asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
- He/She smokes regularly more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
- He/She has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to dosing in first period.
- He/She has a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
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- He/She has a history of alcohol or substance abuse within the last 5 years.
- He/She has clinically significant abnormal values of laboratory parameters.
- He/She has participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- He/She is unable to or likely to be non-compliant with protocol requirements or restrictions.
- He/She, in whom study drug is contraindicated for medical reasons
- He/She is intolerant to venipuncture.
- Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
- Female volunteer demonstrates a positive pregnancy screen. Each female study volunteer will be screened for pregnancy at screening, check-in each study period. Study volunteer with a positive or inconclusive result will be withdrawn from the study.
- Female volunteer is currently breast feeding. Female study volunteer who is pregnant, breast-feeding or who is likely to become pregnant during the study will not be allowed to participate. Female study volunteer of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or she will not be allowed to participate.
- He/She has a positive urine screen for drugs of abuse at the time of admission check-in for each period will be excluded from the study.
- He/She, who meets the inclusion and exclusion criteria, will be verified by medical investigator as per source documents duly authenticated by them reflecting clinical judgment as and when required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single Oral Dose, Two Way Crossover Bioequivalence Study of Atorvastatin Ca 40 mg Tablets of Dr.Reddy's With Lipitor® 40 mg Tablets of Pfizer in 74 Healthy, Adult, Human Subjects Under Fasting Conditions
The purpose of this study is to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions.
Read the detailed description
An open-label, randomized, single oral dose, two way crossover bioequivalence study to compare Atorvastatin Calcium 40 mg Tablets of Dr.Reddy's with Lipitor® 40 mg Tablets of Pfizer in 74 healthy, adult, human study participants under fasting conditions.
- Conditions
- Healthy
- Being tested
- Atorvastatin Calcium Tablets, 40 mg
- Keywords
- Bioequivalence, Atorvastatin calcium, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin Calcium Tablets, 40 mgDrug
Also called Lipitor® 40 mg Tablets
Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin Calcium Tablets, 40 mg | Experimental | Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Atorvastatin Calcium Tablets, 40 mg |
| Lipitor® 40 mg Tablets | Active comparator | Lipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals Receives: Drug: Atorvastatin Calcium Tablets, 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)
Measured: Pre-dose at 0.00, 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 hours and 48.00 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionJul 2009
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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Sudarshan Vishwanath, MD, Principal investigator, Vimta Labs Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645384
- Sponsor's protocol ID
- 01621/09-10
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Oral Dose, Two Way Crossover Bioequivalence Study of Atorvastatin Ca 40 mg Tablets of Dr.Reddy's With Lipitor® 40 mg Tablets of Pfizer in 74 Healthy, Adult, Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01645384
- Acronym / sponsor ID
- 01621/09-10
- Conditions
- Healthy
- Keywords
- Bioequivalence, Atorvastatin calcium, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Jul 2012 (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 purpose of this study is to monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Atorvastatin formulations under fasting conditions.
Detailed description
An open-label, randomized, single oral dose, two way crossover bioequivalence study to compare Atorvastatin Calcium 40 mg Tablets of Dr.Reddy's with Lipitor® 40 mg Tablets of Pfizer in 74 healthy, adult, human study participants under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin Calcium Tablets, 40 mg | Experimental | Drug: Atorvastatin Calcium Tablets, 40 mgAtorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited |
| Lipitor® 40 mg Tablets | Active comparator | Drug: Atorvastatin Calcium Tablets, 40 mgLipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- He/She should provide written informed consent.
- He/She must be a healthy adult within 18-45 years of age (inclusive).
- He/She should have a Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- He/She should have a systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg. Similarly diastolic blood pressure with upper limit less than 90 mm Hg and lower limit more than or equal to 60 mmHg.
- He/She must be of normal health as determined by medical history and physical examination performed within 21 days prior to the dosing of period 1.
Key exclusion criteria (17 listed)
- He/She is incapable of understanding the informed consent.
- He/She has a history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
- He/She has any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy,asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study.
- He/She smokes regularly more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
- He/She has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to dosing in first period.
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 |
|---|---|---|
| Atorvastatin Calcium Tablets, 40 mgAlso: Lipitor® 40 mg TabletsAtorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited | Drug | Atorvastatin Calcium Tablets, 40 mg, Lipitor® 40 mg Tablets |
Primary outcome
Area under curve (AUC)
Time frame: Pre-dose at 0.00, 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 hours and 48.00 hours post dose.
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 20 Jul 2012.
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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.
Dr. Sudarshan Vishwanath, MD principal investigator
Vimta Labs Limited
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 Atorvastatin Calcium Tablets, 40 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
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 17 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 Jul 2012. 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 India. 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?
Area under curve (AUC) (time frame: Pre-dose at 0.00, 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 hours and 48.00 hours post dose.). 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 Jul 2012.