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Cefadroxil 500 mg Capsules Under Fasting Conditions

Information source: Teva Pharmaceuticals USA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Cefadroxil 500 mg Capsules (Drug); DURICEF® capsules 500 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Teva Pharmaceuticals USA

Official(s) and/or principal investigator(s):
Paul Y Tam, M.D., Principal Investigator, Affiliation: Biovail Contract Research

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 Bristol-Myers Squibb Company) when dosed (1 x 500 mg capsules) in normal healthy non-smoking male and female subjects under fasting conditions.

Clinical Details

Official title: 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.

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

Primary outcome:

Cmax (Maximum Observed Concentration)

AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

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

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Eligibility

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

Criteria:

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 ╬▓-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.

Locations and Contacts

Biovail Contract Research, Toronto, Ontario M1L 4R6, Canada

Bioassay Laboratory, Inc., Houston, Texas 77099, United States

Additional Information

Starting date: September 2004
Last updated: August 14, 2009

Page last updated: August 20, 2015

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