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Clarithromycin 500 mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00835692
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 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clarithromycin (Test) First Biaxin® (Reference) First
Hide Arm/Group Description Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
Period Title: First Intervention
Started 28 28
Completed 27 28
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Washout
Started 27 28
Completed 27 28
Not Completed 0 0
Period Title: Second Intervention
Started 27 28
Completed 27 28
Not Completed 0 0
Arm/Group Title Clarithromycin (Test) First Biaxin® (Reference) First Total
Hide Arm/Group Description Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
28
 100.0%
56
 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 28 participants 28 participants 56 participants
Female
2
   7.1%
2
   7.1%
4
   7.1%
Male
26
  92.9%
26
  92.9%
52
  92.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Caucasian 27 23 50
Hispanic 1 2 3
Asian 0 2 2
Black 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 28 participants 56 participants
28 28 56
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 Tablet (test) dosed in either period
Biaxin® 500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng/mL
2170.964  (690.215) 2214.636  (763.844)
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 Mean x 100
Estimated Value 98.4
Confidence Interval 90%
91.5 to 106
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-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 Tablet (test) dosed in either period
Biaxin® 500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
17380.442  (6167.362) 18481.089  (5728.638)
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 93.5
Confidence Interval 90%
89.6 to 97.6
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 (Per Participant)
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 Tablet (test) dosed in either period
Biaxin® 500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
17265.639  (6136.361) 18362.380  (5719.467)
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 93.5
Confidence Interval 90%
89.5 to 97.7
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: NCT00835692     History of Changes
Other Study ID Numbers: R02-663
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