Status:
COMPLETED
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 B...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00835081
Start Date
September 1 2004
End Date
October 1 2004
Last Update
August 19 2024
Active Locations (2)
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1
Bioassay Laboratory, Inc.
Houston, Texas, United States, 77099
2
Biovail Contract Research
Toronto, Ontario, Canada, M1L 4R6