- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835081
Cefadroxil 500 mg Capsules in Normal Healthy Non-Smoking Male and Female Subjects.
August 14, 2009 updated by: Teva Pharmaceuticals USA
A Two-Way , Crossover, Open-Label, Single-Dose, Fed, 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 fed conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M1L 4R6
- Biovail Contract Research
-
-
-
-
Texas
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Houston, Texas, United States, 77099
- Bioassay Laboratory, Inc.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1 x 500 mg
|
Active Comparator: 2
|
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)
Time Frame: Blood samples collected over a 12 hour period.
|
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)
Time Frame: Blood samples collected over a 12 hour period.
|
Bioequivalence based on AUC0-inf.
|
Blood samples collected over a 12 hour period.
|
Cmax (Maximum Observed Concentration)
Time Frame: Blood samples collected over a 12 hour period.
|
Bioequivalence based on Cmax.
|
Blood samples collected over a 12 hour period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul Y Tam, M.D., Biovail Contract Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2921
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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