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To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities

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ClinicalTrials.gov Identifier: NCT01101321
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : May 12, 2010
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Reformulated OXY (Totowa) (oxycodone HCl)
Drug: Reformulated OXY (Wilson) (oxycodone HCl)
Enrollment 58
Recruitment Details 23-Jun-2008 (first Informed Consent Form signed) to 19-Aug-2008 (last subject last visit), at 1 site in the US (Honolulu, HI).
Pre-assignment Details 114 screened; 52 screen failures; 4 withdrew prior to randomization; 58 randomized; 8 terminated early; 50 completed.
Arm/Group Title Reformulated OXY (Totowa) (Test) First Reformulated OXY (Wilson) (Reference) First
Hide Arm/Group Description Reformulated OXY 80-mg tablet (Totowa)(Test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2. Reformulated OXY 80-mg tablet (Wilson) (Reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
Period Title: Period 1
Started 30 28
Completed 26 24
Not Completed 4 4
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             3             3
Period Title: Period 2
Started 26 24
Completed 26 24
Not Completed 0 0
Arm/Group Title Randomized Safety Population
Hide Arm/Group Description Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
Overall Number of Baseline Participants 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants
30  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
22
  37.9%
Male
36
  62.1%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 72-hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.
Arm/Group Title Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Hide Arm/Group Description:
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: ng/mL
78.4  (20.8) 78.2  (20.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reformulated OXY (Totowa) (Test), Reformulated OXY (Wilson) (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 100
Confidence Interval (2-Sided) 90%
96.14 to 104.96
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.
2.Primary Outcome
Title AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 72-hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.
Arm/Group Title Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Hide Arm/Group Description:
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
846  (223) 850  (191)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reformulated OXY (Totowa) (Test), Reformulated OXY (Wilson) (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 98.5
Confidence Interval (2-Sided) 90%
95.44 to 101.73
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.
3.Primary Outcome
Title AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 72-hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population for PK Metrics. Data from all subjects who were randomized, received study drug, and had at least 1 valid PK metric variable were included in the statistical analysis.
Arm/Group Title Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Hide Arm/Group Description:
Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Overall Number of Participants Analyzed 47 50
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
843  (223) 848  (191)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reformulated OXY (Totowa) (Test), Reformulated OXY (Wilson) (Reference)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 98.5
Confidence Interval (2-Sided) 90%
95.42 to 101.70
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.
Time Frame Ongoing AEs-followed until resolution/30 days after last dose;AEs reported during 7 days following last dose were recorded & followed until resolution or up to 30 days after last dose. All SAEs were followed until resolution or event/sequelae stabilized.
Adverse Event Reporting Description AEs were learned of through spontaneous reports, subject interview, or subject diaries.
 
Arm/Group Title Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Hide Arm/Group Description Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
All-Cause Mortality
Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/54 (0.00%)      0/54 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/54 (53.70%)      22/54 (40.74%)    
Gastrointestinal disorders     
Abdominal Pain  1 [1]  4/54 (7.41%)  4 6/54 (11.11%)  6
Nausea  1 [1]  11/54 (20.37%)  16 7/54 (12.96%)  7
Vomiting  1 [1]  8/54 (14.81%)  18 8/54 (14.81%)  19
General disorders     
Fatigue  1 [1]  3/54 (5.56%)  3 4/54 (7.41%)  4
Nervous system disorders     
Dizziness  1 [1]  8/54 (14.81%)  10 6/54 (11.11%)  8
Headache  1 [1]  13/54 (24.07%)  14 8/54 (14.81%)  11
Somnolence  1 [1]  11/54 (20.37%)  12 5/54 (9.26%)  5
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  1 [1]  1/54 (1.85%)  1 4/54 (7.41%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Systematic and nonsystematic assessments were used for reporting AEs.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Leader
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Layout table for additonal information
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01101321     History of Changes
Other Study ID Numbers: OTR1015
First Submitted: April 8, 2010
First Posted: April 9, 2010
Results First Submitted: April 14, 2010
Results First Posted: May 12, 2010
Last Update Posted: November 18, 2015