A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions
NCT ID: NCT01499771
Last Updated: 2012-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2009-10-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Atorvastatin Calcium Tablets of OHM Laboratories Inc.
Atorvastatin
80 Mg tablets
2
LIPITOR® Tablets 80mg of Pfizer Ireland Pharmaceuticals
Atorvastatin
80 Mg tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atorvastatin
80 Mg tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Completed the screening process within four weeks prior to Period I dosing.
3. Healthy male or female, 18 years of age or older at the time of dosing.
4. Body mass index (BMI) between 18 - 32 kg/m2, inclusive, and weighed at least 110 lbs.
5. 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.
6. Female subjects were:
* 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.
Exclusion Criteria
2. 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).
3. Clinical laboratory test values outside the accepted range and when confirmed on re-examination was deemed to be clinically significant.
4. When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
5. Reported a clinically significant illness during the 28 days prior to Period I dosing (as determined by the clinical investigators).
6. Demonstrated a positive drug screen or alcohol breath test.
7. Reported a history of allergic response(s) to atorvastatin or related drugs.
8. Reported a history of clinically significant allergies including food or drug allergies.
9. Reported a history of drug or alcohol addiction or abuse within the past year.
10. 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.
11. 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).
18 Years
66 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cetero Research 4801 Amber Valley Parkway
Fargo, North Dakota, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Related Info
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R09-1033
Identifier Type: -
Identifier Source: org_study_id