Status:
COMPLETED
A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-66 years
Phase:
PHASE1
Brief 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...
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 throu...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
- 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).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01499771
Start Date
October 1 2009
End Date
December 1 2009
Last Update
July 10 2012
Active Locations (1)
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1
Cetero Research 4801 Amber Valley Parkway
Fargo, North Dakota, United States, 58104