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Trial record 7 of 39 for:    Terbinafine

Terbinafine HCl 250 mg Tablet Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00833586
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : August 18, 2009
Last Update Posted : September 25, 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: Terbinafine HCl 250mg tablets
Drug: Lamisil® 250 mg Tablets
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Terbinafine (Test) First Lamisil® (Reference) First
Hide Arm/Group Description Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
Period Title: First Intervention
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Washout: 14 Days
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Second Intervention
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title Terbinafine (Test) First Lamisil® (Reference) First Total
Hide Arm/Group Description Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
28
 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 14 participants 14 participants 28 participants
Female
0
   0.0%
3
  21.4%
3
  10.7%
Male
14
 100.0%
11
  78.6%
25
  89.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Black 4 5 9
Caucasian 8 7 15
Asian 1 0 1
Hispanic 0 2 2
Biracial 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Cmax - Maximum Observed Concentration - Terbinafine in Plasma
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 144 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 Terbinafine Lamisil®
Hide Arm/Group Description:
Terbinafine HCl 250 mg Tablet (test) dosed in either period
Lamisil® 250 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
840.2  (310.8) 873.2  (299.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Terbinafine, Lamisil®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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 95.1
Confidence Interval 90%
85.8 to 105.4
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) - Terbinafine in Plasma
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 144 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 Terbinafine Lamisil®
Hide Arm/Group Description:
Terbinafine HCl 250 mg Tablet (test) dosed in either period
Lamisil® 250 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
4425  (1733) 4062  (2020)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Terbinafine, Lamisil®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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 98.9
Confidence Interval 90%
82.7 to 118.4
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) - Terbinafine in Plasma
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 144 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 Terbinafine Lamisil®
Hide Arm/Group Description:
Terbinafine HCl 250 mg Tablet (test) dosed in either period
Lamisil® 250 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
3795  (1498) 3765  (1636)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Terbinafine, Lamisil®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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 102.4
Confidence Interval 90%
95.0 to 110.5
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
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT00833586     History of Changes
Other Study ID Numbers: 10136024
First Submitted: January 30, 2009
First Posted: February 2, 2009
Results First Submitted: July 6, 2009
Results First Posted: August 18, 2009
Last Update Posted: September 25, 2009