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Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Pravastatin (Drug); Pravastatin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
James D Carlson, Pharm D, Principal Investigator, Affiliation: PRACS Institute, Ltd.


This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd. with that of Pravachol® Tablets 80 mg by Bristol-Myers Squibb Company following a single oral dose (1 x 80 mg tablet)in healthy adult male subjects administered under non-fasting conditions.

Clinical Details

Official title: A Relative Bioavailability Study of 80 mg Pravastatin Sodium Tablets Under Non-Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax - Maximum Observed Concentration - Pravastatin in Plasma

AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Detailed description: Detailed Description Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


Inclusion Criteria

- Screening Demographics: All subjects selected for this study will be healthy men 18

years of age or older at the time of dosing.

- The subject's body mass index (BMI) should be less than or equal to 30.

- Screening Procedures: Each subject will complete the screening process within 28 days

prior to period I dosing.

- Consent documents for both the screening evaluation and HIV antibody determination

will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.

- Screening will include general observations, physical examination, demographics,

medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature.

- The physical examination will include, but may not be limited to, an evaluation of

the cardiovascular, gastrointestinal, respiratory and central nervous systems.

- The screening clinical laboratory procedures will include:

- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count,

platelet count

- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin,

total bilirubin, total protein, and alkaline phosphatase

- HIV antibody, hepatitis GB surface antigen, hepatitis C antibody screens

- URINALYSIS: by dipstick; full microscopic examination if dipstick positive

- URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines,

cannabinoids, cocaine metabolites, opiates and phencyclidine Exclusion Criteria

- Subjects with a recent history of drug or alcohol addiction or abuse.

- Subjects with the presence 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 investigators).

- Subjects whose clinical laboratory test values are outside the accepted reference

range and when confirmed on re-examination are deemed to be clinically significant.

- Subjects demonstrating a reactive screen for hepatitis B surface antigen, hepatitis C

antibody or HIV antibody.

- Subjects demonstrating a positive drug abuse screen when screened for this study.

- Subjects with a history of allergic response(s) to pravastatin or related drugs.

- Subjects with a history of clinically significant allergies including drug allergies.

- Subjects with a clinically significant illness during the 4 weeks prior to Period I

dosing (as determined by the clinical investigators).

- Subjects who currently or report using tobacco products within 90 days of Period I

dose administration.

- Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism

in the 28 days prior to Period I dosing.

- Subjects who report donating greater than 150 mL of blood within 28 days prior to

Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.

- Subjects who have donated plasma (e. g. plasmapheresis) within 14 days prior to Period

I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.

- Subjects who report receiving any investigational drug within 28 days prior to Period

I dosing.

- Subjects who report taking any systemic prescription medication in the 14 days prior

to Period I dosing.

- Subjects who report an intolerance of direct venipuncture.

- Subjects who report consuming an abnormal diet during the 28 days prior to Period I


Locations and Contacts

PRACS Institute, Ltd., Fargo, North Dakota 58104, United States
Additional Information

Starting date: March 2005
Last updated: September 9, 2009

Page last updated: August 23, 2015

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