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Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00829712
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : August 4, 2009
Last Update Posted : August 19, 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: Dexmethylphenidate Hydrochloride
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexmethylphenidate HCl First Focalin® First
Hide Arm/Group Description 10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period. 10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout of 7 Days
Started 12 12
Completed 12 11
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Second Intervention
Started 12 11
Completed 12 11
Not Completed 0 0
Arm/Group Title Dexmethylphenidate HCl First Focalin® First Total
Hide Arm/Group Description 10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period. 10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the 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
6
  50.0%
9
  75.0%
15
  62.5%
Male
6
  50.0%
3
  25.0%
9
  37.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Black 3 2 5
White 8 10 18
Hispanic 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Cmax (Maximum Observed Concentration)
Hide Description Bioequivalence based on Cmax.
Time Frame Blood samples collected over a 16 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Dexmethylphenidate HCl Focalin®
Hide Arm/Group Description:
10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
10 mg Focalin® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: pg/mL
14802.55  (5247.62) 14808.74  (5902.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmethylphenidate HCl, Focalin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products 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 100.95
Confidence Interval 90%
94.02 to 108.39
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 16 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Dexmethylphenidate HCl Focalin®
Hide Arm/Group Description:
10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
10 mg Focalin® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
67045.82  (22261.45) 67210.48  (19529.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmethylphenidate HCl, Focalin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products 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 99.05
Confidence Interval 90%
95.08 to 103.19
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 16 hour period.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed the study had their samples analyzed.
Arm/Group Title Dexmethylphenidate HCl Focalin®
Hide Arm/Group Description:
10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
10 mg Focalin® Tablets reference product dosed in either period.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
69379.08  (22767.19) 68973.94  (20127.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexmethylphenidate HCl, Focalin®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products 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 99.94
Confidence Interval 90%
96.08 to 103.95
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
Name/Title: Manager, Biopharmaceutics
Organization: TEVA Pharmaceuticals USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT00829712     History of Changes
Other Study ID Numbers: 04162
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: June 22, 2009
Results First Posted: August 4, 2009
Last Update Posted: August 19, 2009