Comparative assessment of the absorption of a generic formulation of 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid against the innovator 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid conducted under fasting conditions in healthy male and female volunteers.

Phase 1

Withdrawn

• Conditions: 4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol hydrogen tartrate oral liquid is used to provide temporary relief for persistent unproductive and dry coughs; Anaesthesiology - Pain management; Inflammatory and Immune System - Other inflammatory or immune system disorders; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621001252808
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified