ACTRN12620000812998
Completed
Phase 1
A multiple dose, randomized, open-label, pharmacokinetic study of a generic formulation of 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet in a 2 way crossover comparison against the innovator 5/2.5 mg s 4,5a-epoxy14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride/naloxone tablet administered 12 hours apart conducted under fasting conditions and at steady state in healthy volunteers.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zenith Technology Corporation Limited
- Enrollment
- 33
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy males and non\-pregnant females
- •Aged between 18 and 55 years
- •Non\-smoker
- •BMI greater than or equal to 18\.5 and less than 32 inclusive
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- •Drug free as determined by urine drug testing
- •Able to comply with the study restrictions
- •Able to provide written informed consent
Exclusion Criteria
- •Clinically significant medical conditions
- •History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 30 days of the start of the study
- •Sensitivitie to the study drug or excipients
- •Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Outcomes
Primary Outcomes
Not specified
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