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A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01101308
Recruitment Status : Completed
First Posted : April 9, 2010
Results First Posted : May 11, 2010
Last Update Posted : May 25, 2010
Sponsor:
Information provided by:
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 55
Recruitment Details Study start date: 09-JUL-2008 to end date: 20-Aug-2008, at 1 site in the US (Madison, WI)
Pre-assignment Details 124 screened; 69 screen failures; 0 withdrew; 55 randomized and received study drug; 4 terminated early; 51 completed.
Arm/Group Title Reformulated OXY 10 mg (Totowa) (Test) First Reformulated OXY 10 mg (Wilson) (Reference) First
Hide Arm/Group Description Reformulated OXY 10-mg tablet (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 10-mg tablet Wilson, NC (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 27 28
Completed 24 27
Not Completed 3 1
Reason Not Completed
Adverse Event             2             1
Positive for cotinine             1             0
Period Title: Period 2
Started 24 27
Completed 24 27
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 55
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 55 participants
29  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
26
  47.3%
Male
29
  52.7%
1.Primary Outcome
Title Cmax - Maximum Observed Plasma Concentration
Hide Description Cmax is the maximum observed plasma concentration and bioequivalence is 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. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.
Arm/Group Title Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Hide Arm/Group Description:
Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Reformulated OXY 10-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 53 51
Mean (Standard Deviation)
Unit of Measure: ng/mL
9.81  (2.32) 9.58  (2.52)
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 102
Confidence Interval (2-Sided) 90%
97.51 to 107.27
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 AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is 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. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.
Arm/Group Title Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Hide Arm/Group Description:
Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Reformulated OXY 10-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 53 51
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
112  (26.5) 111  (24.3)
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%
97.19 to 103.00
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 AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is 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. Subjects experiencing emesis within 12 hours after dosing were excluded from PK analysis.
Arm/Group Title Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference)
Hide Arm/Group Description:
Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
Reformulated OXY 10-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 53 51
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
111  (26.4) 110  (24.2)
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%
97.14 to 102.99
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) Prerandomization
Hide Arm/Group Description Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. [Not Specified]
All-Cause Mortality
Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference) Prerandomization
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference) Prerandomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      0/54 (0.00%)      1/124 (0.81%)    
Social circumstances       
Positive drug screen (cannabanoids)  1  0/52 (0.00%)  0 0/54 (0.00%)  0 1/124 (0.81%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Reformulated OXY (Totowa) (Test) Reformulated OXY (Wilson) (Reference) Prerandomization
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/52 (48.08%)      17/54 (31.48%)      0/124 (0.00%)    
Gastrointestinal disorders       
Nausea  1 [1]  6/52 (11.54%)  8 7/54 (12.96%)  10 0/124 (0.00%)  0
General disorders       
Puncture Site Pain  1 [1]  4/52 (7.69%)  5 2/54 (3.70%)  3 0/124 (0.00%)  0
Nervous system disorders       
Dizziness  1 [1]  5/52 (9.62%)  7 3/54 (5.56%)  3 0/124 (0.00%)  0
Headache  1 [1]  6/52 (11.54%)  9 4/54 (7.41%)  4 0/124 (0.00%)  0
Skin and subcutaneous tissue disorders       
Ecchymosis  1 [1]  4/52 (7.69%)  4 1/54 (1.85%)  2 0/124 (0.00%)  0
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: Stephen Harris, MD
Organization: Purdue Pharma L.P.
Phone: 203-588-7592
EMail: Stephen.Harris@Pharma.com
Layout table for additonal information
Responsible Party: Medical Monitor, Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01101308    
Other Study ID Numbers: OTR1013
First Submitted: April 8, 2010
First Posted: April 9, 2010
Results First Submitted: April 14, 2010
Results First Posted: May 11, 2010
Last Update Posted: May 25, 2010