A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
This study has been completed.
Sponsor:
Purdue Pharma LP
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01100086
First received: April 6, 2010
Last updated: May 17, 2010
Last verified: May 2010
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Results First Received: April 13, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label |
| Condition: |
Healthy Volunteers |
| Interventions: |
Drug: Reformulated OXY (oxycodone HCl) Drug: Original OxyContin® (OXY) (oxycodone HCl) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 02-Jan-2007 to 06-Mar-2007 at 1 site in the US (Madison, WI) |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 167 subjects screened; 83 screen failures; 84 randomized; 1 terminated early; 83 completed |
Reporting Groups
| Description | |
|---|---|
| Reformulated OXY (Test) First | Reformulated OXY 10-mg tablet (test) dosed fasted was 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 (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2. |
| Original OxyContin® (OXY) (Reference) First | Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted was 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 Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2. |
Participant Flow for 2 periods
Period 1: Period 1
| Reformulated OXY (Test) First | Original OxyContin® (OXY) (Reference) First | |
|---|---|---|
| STARTED | 43 | 41 |
| COMPLETED | 42 | 41 |
| NOT COMPLETED | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
Period 2: Period 2
| Reformulated OXY (Test) First | Original OxyContin® (OXY) (Reference) First | |
|---|---|---|
| STARTED | 42 | 41 |
| COMPLETED | 42 | 41 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Randomized Safety Population | Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment. |
Baseline Measures
| Randomized Safety Population | |
|---|---|
|
Number of Participants
[units: participants] |
84 |
|
Age
[units: years] Mean ± Standard Deviation |
32 ± 9.3 |
|
Gender
[units: participants] |
|
| Female | 27 |
| Male | 57 |
Outcome Measures
| 1. Primary: | Cmax - Maximum Observed Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ] |
| 2. Primary: | AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 72-hour period ] |
| 3. Primary: | AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration [ Time Frame: Blood samples collected over 72-hour period ] |