A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions

NCT01499771 | Completed Phase 1

• 1 other identifier: R09-1033
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of Atorvastatin.

  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.

Study Arms (2)

1

EXPERIMENTAL

Atorvastatin Calcium Tablets of OHM Laboratories Inc.

Drug: Atorvastatin

2

ACTIVE COMPARATOR

LIPITOR® Tablets 80mg of Pfizer Ireland Pharmaceuticals

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

80 Mg tablets

1; 2

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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).
• \. Demonstrates a positive pregnancy screen (female only).

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Cetero Research 4801 Amber Valley Parkway

Fargo, North Dakota, 58104, United States

Location

Related Links

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MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: October 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

US (1)