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Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00835549
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : July 21, 2009
Last Update Posted : August 20, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE January 30, 2009
First Posted Date  ICMJE February 3, 2009
Results First Submitted Date  ICMJE June 18, 2009
Results First Posted Date  ICMJE July 21, 2009
Last Update Posted Date August 20, 2009
Study Start Date  ICMJE March 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 14 hour period. ]
  • AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 14 hour period. ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 14 hour period. ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2009)
Bioequivalence based on Cmax and AUC [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT00835549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting
Official Title  ICMJE A Relative Bioavailability Study of Cefdinir for Oral Suspension 250 mg/5mL Under Non-Fasting Conditions
Brief Summary The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL (Abbott) in healthy, adult, non-smoking subjects under non-fasting conditions.
Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Cefdinir for oral suspension 250 mg/5mL
    1 x 250 mg/5mL, single-dose non-fasting
  • Drug: OMNICEF® for oral suspension 250 mg/5mL
    1 x 250 mg/5mL, single-dose non-fasting
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Cefdinir for oral suspension 250 mg/5mL
  • Active Comparator: 2
    Intervention: Drug: OMNICEF® for oral suspension 250 mg/5mL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2009)
32
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) between 19 kg/m² and 30 kg/m² (inclusive).
  • Each subject will be given a general physical examination within 28 days of initiation of the study. Such examination includes but is not limited to blood pressure, general observations, and history.
  • Each female subject will be given a serum pregnancy test as part of the pre-study screening process.
  • Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the trial for clinical laboratory measurements.

Clinical laboratory measurements will include the following:

  • Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).
  • Clinical Chemistry: creatinine, BUN, glucose, SGOT, SGPT, bilirubin, and alkaline phosphatase.
  • Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
  • HIV Screen
  • Hepatitis-B, C Screen
  • Drugs of Abuse Screen: pre-study and at each dosing period check-in

Subjects will be selected if all above are normal. Electrocardiograms of all participating subjects will be recorded before initiation of the study and filed with each subject's case report forms.

Exclusion Criteria:

  • Subjects with a history of alcoholism or drug addiction (during past 2 years) or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are outside the reference range may be retested at the discretion of the clinical investigator. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested (including penicillin, any penicillin derivative, or any cephalosporin product) should be excluded from the study.
  • All subjects will have urine/saliva samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each study period check-in. Subjects found to have urin/saliva concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study dosing, or used oral hormonal contraceptives within 14 days before dosing will not be allowed to participate.
  • All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is require.

Subjects who have difficulty fasting or consuming the standard meals will not be allowed to participate.

  • Subjects who have had a clinically significant illness within 4 weeks prior to the first dosing of the study will not be allowed to participate.

Subjects who have used a known hepatic enzyme inducer or inhibitor within 30 days prior to the first dosing of the study will not be allowed to participate.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835549
Other Study ID Numbers  ICMJE B056502
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Teva Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Soran Hong, M.D. Novum Pharmaceutical Research Services
PRS Account Teva Pharmaceuticals USA
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP