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Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00840411
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : July 21, 2009
Last Update Posted : September 11, 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: Clarithromycin ER 500 mg tablets
Drug: BIAXIN® XL 500 mg tablets
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clarithromycin (Test) First Biaxin® XL (Reference) First
Hide Arm/Group Description Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period. Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
Period Title: First Intervention
Started 33 33
Completed 32 33
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Washout
Started 32 33
Completed 31 33
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Second Intervention
Started 31 33
Completed 31 33
Not Completed 0 0
Arm/Group Title Clarithromycin (Test) First Biaxin® XL (Reference) First Total
Hide Arm/Group Description Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period. Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
  97.0%
32
  97.0%
64
  97.0%
>=65 years
1
   3.0%
1
   3.0%
2
   3.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
5
  15.2%
6
  18.2%
11
  16.7%
Male
28
  84.8%
27
  81.8%
55
  83.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Caucasian 24 29 53
Black 9 4 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 66 participants
33 33 66
1.Primary Outcome
Title Cmax - Maximum Observed Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from subjects who completed the study were included in the statistical analysis.
Arm/Group Title Clarithromycin Biaxin® XL
Hide Arm/Group Description:
Clarithromycin 500 mg ER Tablet (test) dosed in either period
Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
Overall Number of Participants Analyzed 62 62
Mean (Standard Deviation)
Unit of Measure: ng/mL
640.08  (214.223) 640.11  (231.752)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Biaxin® XL
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 100.0
Confidence Interval 90%
93.3 to 107.1
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
2.Primary Outcome
Title AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
AUCinf could not be estimated for some subjects.
Arm/Group Title Clarithromycin Biaxin® XL
Hide Arm/Group Description:
Clarithromycin 500 mg ER Tablet (test) dosed in either period
Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
Overall Number of Participants Analyzed 62 58
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
10255.3  (4102.34) 11767.7  (5131.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Biaxin® XL
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Least Squares Means
Estimated Value 86.5
Confidence Interval 90%
80.1 to 93.4
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
3.Primary Outcome
Title AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from subjects who completed the study were included in the statistical analysis.
Arm/Group Title Clarithromycin Biaxin® XL
Hide Arm/Group Description:
Clarithromycin 500 mg ER Tablet (test) dosed in either period
Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
Overall Number of Participants Analyzed 62 62
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
9735.5  (3813.66) 11136.6  (4412.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Biaxin® XL
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Ratio of Least Squares Means
Estimated Value 87.2
Confidence Interval 90%
81.0 to 93.8
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 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.
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: NCT00840411     History of Changes
Other Study ID Numbers: 02197
First Submitted: February 6, 2009
First Posted: February 10, 2009
Results First Submitted: June 18, 2009
Results First Posted: July 21, 2009
Last Update Posted: September 11, 2009