Cefadroxil 500 mg Capsules Under Fasting Conditions

A Two-Way Crossover, Open-Label, Single-Dose Fasting, Bioequivalence Study of Cefadroxil 500 mg Capsules Versus DURICEF® 500 mg Capsules in Normal Healthy Non-smoking Male and Female Subjects.

The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fasting conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Cefadroxil 500 mg Capsules; Drug: DURICEF® capsules 500 mg

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M1L 4R6
      • Biovail Contract Research
• United States
  • Texas
    • Houston, Texas, United States, 77099
      • Bioassay Laboratory, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening.
• Body mass index (BMI= weight/height2 greater than or equal to 19kg/m2 and less than or equal to 30kg/m2.
• Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.
• Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8°C and 37.5°C.
• Negative for drugs of abuse nicotine, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum β-CG).
• No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides the are not clinically significant.
• Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.

Exclusion Criteria:

• Known history of hypersensitivity to cefadroxil (e.g. Duricel®) and/or related drugs in the family of cephalosporins (Cephalexin, Cefaclor, Cefazolin, Cefuroxime Axetil, Cefotetan, Cefprozil, Cefixime, Ceftriaxone), and/or penicillins (Amoxicillin, Ampicillin, Clozacillin).
• Known history or presence of fod allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
• Any clinically significant illness during the last four weeks prior to entry into this study.
• Presence of andy significant physical or organ abnormality.
• Any subject with a history of drug abuse.
• Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
• Use of any prescription medication within 14 days preceding entry into this study.
• Use of over-the-counter (OTC) medication within 14 days preceding entry into this study (except for spermicidal/barrier contraceptive products).
• Female subjects: use of contraceptives( oral, transdermal, implant, Mirena® IUD) within 30 days prior to drug administration or a depot injection or progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
• Female subjects: presence of pregnancy or lactation.
• Any subject who has had blood drawn within 56 days preceding this study, during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
• Participation in a clinical trial with an investigational drug within 30 days preceding this study.
• Any subject who has donated blood within 56 days preceding this study.
• Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
• Significant or recent history of asthma (after 12 years of age).
• Any subject with a recent(less than one year) history of alcohol abuse.
• Known personal history of gastrointestinal illness or disease, particularly colitis.
• Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
• Intolerance to venipuncture.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Cefadroxil 500 mg Capsules; 1 x 500 mg
Active Comparator: 2	Drug: DURICEF® capsules 500 mg; 1 x 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Bioequivalence based on AUC0-t.	Blood samples collected over a 12 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	Bioequivalence based on AUC0-inf.	Blood samples collected over a 12 hour period.
Cmax (Maximum Observed Concentration)	Bioequivalence based on Cmax.	Blood samples collected over a 12 hour period

Collaborators and Investigators

• Sponsor: Teva Pharmaceuticals USA
• Investigators: Principal Investigator: Paul Y Tam, M.D., Biovail Contract Research

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): October 1, 2004
• Study Completion (Actual): October 1, 2004

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): August 20, 2009
• Last Update Submitted That Met QC Criteria: August 14, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Subjects
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Cefadroxil
• Other Study ID Numbers: 2920