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Trial record 49 of 389 for:    CLARITHROMYCIN

Clarithromycin 500 mg Tablets Under Non-Fasting Conditions

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: NCT00836706
Recruitment Status : Completed
First Posted : February 4, 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
Drug: BIAXIN®
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clarithromycin (Test) First Biaxin® (Reference) First
Hide Arm/Group Description Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period. Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
Period Title: First Intervention
Started 11 12
Completed 11 12
Not Completed 0 0
Period Title: Washout: 7 Days
Started 11 12
Completed 11 11
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Second Intervention
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Clarithromycin (Test) First Biaxin® (Reference) First Total
Hide Arm/Group Description Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period. Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period. Total of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
12
 100.0%
23
 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 11 participants 12 participants 23 participants
Female
1
   9.1%
0
   0.0%
1
   4.3%
Male
10
  90.9%
12
 100.0%
22
  95.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Caucasian 11 10 21
Black 0 1 1
Asian 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 23 participants
11 12 23
1.Primary Outcome
Title Cmax - Maximum Observed Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 48 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Clarithromycin Biaxin®
Hide Arm/Group Description:
Clarithromycin 500 mg Tablets (test) dosed in either period
Biaxin® 500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng/mL
2440.545  (764.773) 2414.955  (859.636)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Biaxin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 101
Confidence Interval 90%
85.2 to 120
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 48 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Clarithromycin Biaxin®
Hide Arm/Group Description:
Clarithromycin 500 mg Tablets (test) dosed in either period
Biaxin® 500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
13509.616  (4764.228) 13278.682  (4643.690)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Biaxin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 101
Confidence Interval 90%
88.7 to 114
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 48 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Clarithromycin Biaxin®
Hide Arm/Group Description:
Clarithromycin 500 mg Tablets (test) dosed in either period
Biaxin® 500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
13424.597  (4778.315) 13192.468  (4606.320)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Biaxin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 101
Confidence Interval 90%
88.4 to 114
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
Layout table for Results Point of Contact information
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00836706     History of Changes
Other Study ID Numbers: R02-664
First Submitted: February 2, 2009
First Posted: February 4, 2009
Results First Submitted: June 18, 2009
Results First Posted: July 21, 2009
Last Update Posted: September 11, 2009