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Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00829790
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : August 4, 2009
Last Update Posted : August 20, 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
Intervention Drug: Doxycycline Monohydrate
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxycycline Monohydrate First Vibramycin® Monohydrate First
Hide Arm/Group Description 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period. 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
Period Title: First Intervention
Started 15 15
Completed 15 15
Not Completed 0 0
Period Title: Washout of 14 Days
Started 15 15
Completed 15 14
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Second Intervention
Started 15 14
Completed 15 14
Not Completed 0 0
Arm/Group Title Doxycycline Monohydrate First Vibramycin® Monohydrate First Total
Hide Arm/Group Description 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period. 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period. Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  93.3%
15
 100.0%
29
  96.7%
>=65 years
1
   6.7%
0
   0.0%
1
   3.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
10
  66.7%
7
  46.7%
17
  56.7%
Male
5
  33.3%
8
  53.3%
13
  43.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Black 1 3 4
White 4 8 12
Hispanic 9 4 13
More than One 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title Cmax = Maximum Observed Concentration.
Hide Description Bioequivalence based on Cmax.
Time Frame Blood samples collected over a 72 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Doxycycline Monohydrate Vibramycin® Monohydrate
Hide Arm/Group Description:
25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: ng/mL
295  (77.8) 256  (65.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Monohydrate, Vibramycin® Monohydrate
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 114.49
Confidence Interval 90%
109.25 to 119.98
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
2.Primary Outcome
Title AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration.
Hide Description Bioequivalence based on AUC0-t.
Time Frame Blood samples collected over a 72 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Doxycycline Monohydrate Vibramycin® Monohydrate
Hide Arm/Group Description:
25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5869  (1449) 4991  (1216)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Monohydrate, Vibramycin® Monohydrate
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 117.16
Confidence Interval 90%
110.44 to 124.28
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.
3.Primary Outcome
Title AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
Hide Description Bioequivalence based on AUC0-inf.
Time Frame Blood samples collected over a 72 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Doxycycline Monohydrate Vibramycin® Monohydrate
Hide Arm/Group Description:
25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
6330  (1417) 5413  (1206)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Doxycycline Monohydrate, Vibramycin® Monohydrate
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).
Method of Estimation Estimation Parameter Ratio of the T/R geometric mean x 100
Estimated Value 116.7
Confidence Interval 90%
109.89 to 123.92
Estimation Comments Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 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.
The 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: NCT00829790     History of Changes
Other Study ID Numbers: 20-065-SA
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: June 30, 2009
Results First Posted: August 4, 2009
Last Update Posted: August 20, 2009