HealthyPhase 1NCT01499771
A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions
A Phase 1 study testing Atorvastatin in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of 80 mg LIPITOR® Tablets (containing atorvastatin… Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed of the nature of the study, had agreed to, and was able to read, review, and sign the informed consent document prior to Period I dosing. The informed consent document was written in English, therefore the volunteer must have had the ability to read and communicate in English.
- Completed the screening process within four weeks prior to Period I dosing.
- Healthy male or female, 18 years of age or older at the time of dosing.
- Body mass index (BMI) between 18 - 32 kg/m2, inclusive, and weighed at least 110 lbs.
- Generally healthy as documented by medical history, physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), vital sign assessments, 12-lead ECG, clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the acceptable range that might have been considered clinically relevant by the study physician or investigator were evaluated as individual cases, documented in study files, and agreed upon by the principal investigator (or sub-investigator) prior to enrolling the subject in this study.
- Female subjects were:
Show all 9Show fewer
- of postmenopausal status (no menses) for at least one year and if < 55 years of age had documented FSH level ≥ 40 mIU/mL; or,
- sterile [surgically (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or the Essure® Procedure].
- Fe Female subjects that were surgically sterile were to provide documentation of the bilateral tubal ligation, bilateral oophorectomy, or hysterectomy prior to Period I dosing. The Essure® Procedure must have been inserted at least 3 months prior with documentation of the Essure® confirmation test prior to Period I dosing.
Who cannot join
- Reported receiving any investigational drug within 28 days prior to Period I dosing.
- Reported any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Clinical laboratory test values outside the accepted range and when confirmed on re-examination was deemed to be clinically significant.
- When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Reported a clinically significant illness during the 28 days prior to Period I dosing (as determined by the clinical investigators).
- Demonstrated a positive drug screen or alcohol breath test.
Show all 13Show fewer
- Reported a history of allergic response(s) to atorvastatin or related drugs.
- Reported a history of clinically significant allergies including food or drug allergies.
- Reported a history of drug or alcohol addiction or abuse within the past year.
- Reported donating blood within 28 days prior to Period I dosing. All subjects were to be advised not to donate blood for four weeks after completing the study.
- Reported donating plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects were to be advised not to donate plasma for four 12. weeks after completing the study.
- 13. Reported an intolerance of direct venipuncture. 14. Reported difficulty fasting or consuming standardized meals. 15. Reported difficulty swallowing tables or capsules whole. 16. Pregnant, lactating, breastfeeding, or intended to become pregnant over the course of the study (females only).
- 17. Demonstrates a positive pregnancy screen (female only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cetero Research 4801 Amber Valley Parkway
Fargo, North Dakota, 58104
About this study
Official title: A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions.
This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of 80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80 mg tablet) in healthy adult subjects when administered under fed conditions.
Read the detailed description
This was an open-label, balanced, randomized, two-period, two-treatment, two-sequence, single-dose crossover bioequivalence study under fed conditions. The total duration of the study, screening through study exit, was approximately 8 weeks with at least a 14-day washout period between doses. At study check-in, the subjects reported to the clinical site at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after dose administration at 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours. A total of 25 blood samples were collected per study period for a total of 50 samples or 150 mL total volume.
- Conditions
- Healthy
- Being tested
- Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
80 Mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Atorvastatin Calcium Tablets of OHM Laboratories Inc. Receives: Drug: Atorvastatin |
| 2 | Active comparator | LIPITOR® Tablets 80mg of Pfizer Ireland Pharmaceuticals Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Atorvastatin.
Measured: 0, 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionDec 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499771
- Sponsor's protocol ID
- R09-1033
- Status last verified
- Jul 2012
- First submitted
- 20 Dec 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01499771
- Acronym / sponsor ID
- R09-1033
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Dec 2011 (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 study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of 80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin) distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80 mg tablet) in healthy adult subjects when administered under fed conditions.
Detailed description
This was an open-label, balanced, randomized, two-period, two-treatment, two-sequence, single-dose crossover bioequivalence study under fed conditions. The total duration of the study, screening through study exit, was approximately 8 weeks with at least a 14-day washout period between doses. At study check-in, the subjects reported to the clinical site at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after dose administration at 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours. A total of 25 blood samples were collected per study period for a total of 50 samples or 150 mL total volume.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AtorvastatinAtorvastatin Calcium Tablets of OHM Laboratories Inc. |
| 2 | Active comparator | Drug: AtorvastatinLIPITOR® Tablets 80mg of Pfizer Ireland Pharmaceuticals |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed of the nature of the study, had agreed to, and was able to read, review, and sign the informed consent document prior to Period I dosing. The informed consent document was written in English, therefore the volunteer must have had the ability to read and communicate in English.
- Completed the screening process within four weeks prior to Period I dosing.
- Healthy male or female, 18 years of age or older at the time of dosing.
- Body mass index (BMI) between 18 - 32 kg/m2, inclusive, and weighed at least 110 lbs.
- Generally healthy as documented by medical history, physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), vital sign assessments, 12-lead ECG, clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the acceptable range that might have been considered clinically relevant by the study physician or investigator were evaluated as individual cases, documented in study files, and agreed upon by the principal investigator (or sub-investigator) prior to enrolling the subject in this study.
Key exclusion criteria (13 listed)
- Reported receiving any investigational drug within 28 days prior to Period I dosing.
- Reported any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Clinical laboratory test values outside the accepted range and when confirmed on re-examination was deemed to be clinically significant.
- When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Reported a clinically significant illness during the 28 days prior to Period I dosing (as determined by the clinical investigators).
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 |
|---|---|---|
| Atorvastatin80 Mg tablets | Drug | 1, 2 |
Primary outcome
Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Atorvastatin.
Time frame: 0, 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours.
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 10 Jul 2012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Atorvastatin in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
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 9 inclusion and 13 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 10 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 United States. 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 the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Atorvastatin. (time frame: 0, 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 36, 48, 60, 72, and 96 hours.). 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 10 Jul 2012.