Cefadroxil 500 mg Capsules Under Fasting Conditions

NCT00834275 | Completed Phase 1 Results

• 1 other identifier: 2920
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 2

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

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax (Maximum Observed Concentration)

  Bioequivalence based on Cmax.

  Blood samples collected over a 12 hour period

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: Cefadroxil 500 mg Capsules

2

ACTIVE COMPARATOR

Drug: DURICEF® capsules 500 mg

Interventions

Cefadroxil 500 mg Capsules DRUG

1 x 500 mg

1

DURICEF® capsules 500 mg DRUG

1 x 500 mg

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (2)

Bioassay Laboratory, Inc.

Houston, Texas, 77099, United States

Location

Biovail Contract Research

Toronto, Ontario, M1L 4R6, Canada

Location

MeSH Terms

Interventions

Cefadroxil

Intervention Hierarchy (Ancestors)

Cephalexin; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: TEVA Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Paul Y Tam, M.D.

  Biovail Contract Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: September 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: August 19, 2024
• Results First Posted: July 21, 2009

Record last verified: 2024-08

Locations

US (1); CA (1)