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Cefdinir for Oral Suspension 250 mg/5mL, Fasting

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ClinicalTrials.gov Identifier: NCT00834574
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Cefdinir for oral suspension 250 mg/5mL
Drug: OMNICEF® for oral suspension 250 mg/5mL
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cefdinir (Test) First Omnicef® (Reference) First
Hide Arm/Group Description 250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period. 250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
Period Title: First Intervention
Started 16 16
Completed 16 16
Not Completed 0 0
Period Title: Washout of 7 Days
Started 16 16
Completed 16 16
Not Completed 0 0
Period Title: Second Intervention
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title Cefdinir (Test) First Omnicef® (Reference) First Total
Hide Arm/Group Description 250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period. 250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period. Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
16
 100.0%
32
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
8
  50.0%
4
  25.0%
12
  37.5%
Male
8
  50.0%
12
  75.0%
20
  62.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Black 6 10 16
White 10 6 16
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
8
  50.0%
3
  18.8%
11
  34.4%
Not Hispanic or Latino
8
  50.0%
13
  81.3%
21
  65.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Cmax (Maximum Observed Concentration)
Hide Description Bioequivalence based on Cmax.
Time Frame Blood samples collected over a 14 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Cefdinir (Test) Omnicef® (Reference)
Hide Arm/Group Description:
250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: ng/mL
2638.063  (775.044) 2557.122  (732.845)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cefdinir (Test), Omnicef® (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 103
Confidence Interval 90%
97.2 to 110
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
2.Primary Outcome
Title AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Hide Description Bioequivalence based on AUC0-t.
Time Frame Blood samples collected over a 14 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Cefdinir (Test) Omnicef® (Reference)
Hide Arm/Group Description:
250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
12426.232  (4330.683) 11568.479  (3962.398)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cefdinir (Test), Omnicef® (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 107
Confidence Interval 90%
101 to 114
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
3.Primary Outcome
Title AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Hide Description Bioequivalence based on AUC0-inf.
Time Frame Blood samples collected over a 14 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Cefdinir (Test) Omnicef® (Reference)
Hide Arm/Group Description:
250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
12553.808  (4459.202) 11680.224  (4055.085)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cefdinir (Test), Omnicef® (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 107
Confidence Interval 90%
101 to 114
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Name/Title: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT00834574     History of Changes
Other Study ID Numbers: B056501
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: June 18, 2009
Results First Posted: July 21, 2009
Last Update Posted: August 20, 2009