None listed
Conditions
Brief summary
The objective of this study is to evaluate the pharmacokinetics and efficacy of the test formulation relative to that of a reference formulation and placebo, following oral administration of a single dose of 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid to healthy male and female subjects under fasting conditions.
Interventions
Single dose, three-treatment, three-period, six-sequence, crossover design whereby each participant receives the test formulation of 3 x 10 mL of 9.5 mg/5mL 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid on one occasion and the innovator formulation of 3 x 10 mL of 9.5 mg/5mL 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid on one occasion and the placebo of 3 x 10 mL oral placebo liquid on one occasion with each dose separated by a one week wa
Single dose, three-treatment, three-period, six-sequence, crossover design whereby each participant receives the test formulation of 3 x 10 mL of 9.5 mg/5mL 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid on one occasion and the innovator formulation of 3 x 10 mL of 9.5 mg/5mL 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid on one occasion and the placebo of 3 x 10 mL oral placebo liquid on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test formulation of 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid. No water is allowed for 1 hour prior to dosing until 1 hour after dosing. Participants are required not to eat for 10 hours prior to dosing and for approximately 4 hours after receiving each dose. Following this period of fasting standard meals will be consumed at the Clinical Site with no additional food intake allowed. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 24 hours post-dosing. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants. Each dose will be taken orally. Medication must be swallowed and a mouth check will be conducted to ensure the medication has been taken as directed.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy males and non-pregnant female volunteers. Aged between 18 and 50 Non-smoker BMI between 18 and 32 Absence of any cough or cold within 2 weeks prior to dosing. Normal spirometry measurements (FEV1). Cough response reached in the Citric Acid Provocation test at screening and pre-dose. Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests. Able to provide written informed consent.
Exclusion criteria
Concomitant drug therapy of any kind Any clinically significant medical conditions Sensitive to the study drug History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug No cough response reached at any concentration of the citric acid test during screening. History of bronchial asthma, chronic obstructive pulmonary disease (COPD). History of recent head injuries, constipation, hypothyroidism or sleep apnoea Females who are pregnant and/or breastfeeding Smoker (anyone who has smoked in the last 6 months) History of alcohol or drug abuse or dependency Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study Participants for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Outcome results
None listed