To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Reformulated OXY (Wilson) (oxycodone HCl)Drug: Reformulated OXY (Totowa) (oxycodone HCl)
- Registration Number
- NCT01101321
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.
- Detailed Description
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Males and females aged 18 to 50, inclusive.
- Body weight ranging from 50 to 100 kg and a BMI ≥18 and ≤34 (kg/m2).
- Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, and ECG.
- Females of child-bearing potential must be using an adequate and reliable method of contraception.
Exclusion Criteria
- Females who are pregnant or lactating.
- Any history of or current drug or alcohol abuse for 5 years.
- History of or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of an opioid-containing medication in the past 30 days.
- History of known sensitivity to oxycodone, naltrexone, or related compounds.
- Any history of frequent nausea or emesis regardless of etiology.
- Any history of seizures or head trauma with current sequelae.
- Participation in a clinical drug study during the 30 days preceding the initial dose in this study.
- Any significant illness during the 30 days preceding the initial dose in this study.
- Use of any medication including thyroid hormone replacement therapy (hormonal contraception is allowed), vitamins, herbal, and/or mineral supplements, during the 7 days preceding the initial dose.
- Refusal to abstain from food for 4 hours following administration of the study drugs and to abstain from caffeine or xanthine entirely during each confinement.
- Consumption of alcoholic beverages within forty-eight (48) hours of initial study drug administration (Day 1) or anytime following initial study drug administration.
- History of smoking or use of nicotine products within 45 days of study drug administration or a positive urine cotinine test.
- Blood or blood products donated within 30 days prior to administration of the study drugs or anytime during the study, except as required by this protocol.
- Positive results for urine drug screen or alcohol screen at Check-in of each period, and HBsAg, HBsAb (unless immunized), anti-HCV.
- Positive Naloxone HCl challenge test.
- Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Reformulated OXY 80 mg (Wilson) Reformulated OXY (Wilson) (oxycodone HCl) Reformulated OXY 80 mg (Wilson) x 1 dose Reformulated OXY 80 mg (Totowa) Reformulated OXY (Totowa) (oxycodone HCl) Reformulated OXY 80 mg (Totowa) x 1 dose
- Primary Outcome Measures
Name Time Method Cmax - Maximum Observed Plasma Concentration Blood samples collected over 72-hour period Bioequivalence based on Cmax
AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated) Blood samples collected over 72-hour period Bioequivalence based on AUC0-inf
AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration Blood samples collected over 72-hour period Bioequivalence based on AUC0-t
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Covance Clinical Research Unit Honolulu
🇺🇸Honolulu, Hawaii, United States