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Trial record 34 of 231 for:    clindamycin

Clindamycin 300 mg Capsules in Healthy Subjects Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00836056
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: Clindamycin 300 mg capsule
Drug: Cleocin HCl 300 mg capsules
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clindamycin (Test) First Cleocin® (Reference) First
Hide Arm/Group Description Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
Period Title: First Intervention
Started 12 12
Completed 11 12
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Washout: 7 Days
Started 11 12
Completed 11 12
Not Completed 0 0
Period Title: Second Intervention
Started 11 12
Completed 11 12
Not Completed 0 0
Arm/Group Title Clindamycin (Test) First Cleocin® (Reference) First Total
Hide Arm/Group Description Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 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 12 participants 12 participants 24 participants
Female
8
  66.7%
6
  50.0%
14
  58.3%
Male
4
  33.3%
6
  50.0%
10
  41.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Bioequivalence Based on Cmax
Hide Description Cmax - Maximum Observed Concentration
Time Frame Blood samples collected over 24 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 Clindamycin Cleocin®
Hide Arm/Group Description:
Clindamycin 300 mg Capsule (test) dosed in either period
Cleocin® 300 mg Capsule (reference) dosed in either period
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
3008.88  (860.12) 3086.02  (988.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin, Cleocin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 97.75
Confidence Interval 90%
91.50 to 104.42
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
2.Primary Outcome
Title Bioequivalence Based on AUCinf
Hide Description AUCinf - Area under the concentration-time curve from time zero to infinity (extrapolated)
Time Frame Blood samples collected over 24 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 Clindamycin Cleocin®
Hide Arm/Group Description:
Clindamycin 300 mg Capsule (test) dosed in either period
Cleocin® 300 mg Capsule (reference) dosed in either period
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
10646.98  (3549.49) 10890.41  (3297.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin, Cleocin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 96.77
Confidence Interval 90%
91.40 to 102.46
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
3.Primary Outcome
Title Bioequivalence Based on AUC0-t
Hide Description AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration
Time Frame Blood samples collected over 24 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 Clindamycin Cleocin®
Hide Arm/Group Description:
Clindamycin 300 mg Capsule (test) dosed in either period
Cleocin® 300 mg Capsule (reference) dosed in either period
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
10218.56  (3500.68) 10504.80  (3172.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clindamycin, Cleocin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 95.96
Confidence Interval 90%
90.77 to 101.46
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: NCT00836056     History of Changes
Other Study ID Numbers: 30312
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: June 18, 2009
Results First Posted: July 21, 2009
Last Update Posted: September 11, 2009