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Trial record 99 of 396 for:    CLARITHROMYCIN

Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.

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ClinicalTrials.gov Identifier: NCT00840216
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 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clarithromycin (Test) First Biaxin® (Reference) First
Hide Arm/Group Description Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
Period Title: First Intervention
Started 11 11
Completed 11 11
Not Completed 0 0
Period Title: Washout: 7 Days
Started 11 11
Completed 10 11
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Second Intervention
Started 10 11
Completed 10 11
Not Completed 0 0
Arm/Group Title Clarithromycin (Test) First Biaxin® (Reference) First Total
Hide Arm/Group Description Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period Biaxin® XL Filmtab® 500 mg (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 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  90.9%
10
  90.9%
20
  90.9%
>=65 years
1
   9.1%
1
   9.1%
2
   9.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female
5
  45.5%
6
  54.5%
11
  50.0%
Male
6
  54.5%
5
  45.5%
11
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Caucasian 9 10 19
Black 2 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
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®
Hide Arm/Group Description:
Clarithromycin 500 mg ER Tablets (test) dosed in either period
Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
1515.00  (533.782) 1464.10  (700.030)
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 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 106.9
Estimation Comments Bioequivalence is established when the ratio of the mean 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
Data from subjects who completed the study were included in the statistical analysis.
Arm/Group Title Clarithromycin Biaxin®
Hide Arm/Group Description:
Clarithromycin 500 mg ER Tablets (test) dosed in either period
Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
14449.3  (4684.11) 15699.8  (5991.11)
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 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 92.7
Estimation Comments Bioequivalence is established when ratio of the mean 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®
Hide Arm/Group Description:
Clarithromycin 500 mg ER Tablets (test) dosed in either period
Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
14236.7  (4681.28) 15389.5  (5923.27)
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 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 93.0
Estimation Comments Bioequivalence is established when ratio of the mean 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: NCT00840216     History of Changes
Other Study ID Numbers: 02198
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