Comparative assessment of the absorption of a generic formulation of 50 mg desvenlafaxine extended release tablet against the innovator 50 mg desvenlafaxine extended release tablet conducted under fasting conditions in healthy male and female volunteers

Phase 1

Completed

• Conditions: Bioequivalence study conducted in healthy volunteers comparing two formulations of desvenlafaxine with no health condition or problem studied. Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, desvenlafaxine belongs to a class of medicines called Serotonin-Nonadrenaline Reuptake Inhibitors and is an antidepressant prescribed for the treatment and prevention of relapse of depression.; Bioequivalence study conducted in healthy volunteers comparing two formulations of desvenlafaxine with no health condition or problem studied.; Although this study is being conducted in healthy volunteers who are not being treated for the condition to which the medicine is used, desvenlafaxine belongs to a class of medicines called Serotonin-Nonadrenaline Reuptake Inhibitors and is an antidepressant prescribed for the treatment and prevention of relapse of depression.; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12613000622707
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Healthy males and Females
Aged between 18 and 55
Non-smoker
BMI between 19 and 30
Normal, healthy individuals as determined by medical history, physical examination, ECG, bood pressure and laboratory tests
Able to provide written informed consent

Exclusion Criteria

Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind (excluding prescribed hormonal contraceptives
History of depression, anxiety, obsessive-compulsive disorder, or post-traumatic stress syndrome
Pregnant or breast-feeding
Sensitivity to desvenlafaxine, any antidepressant agens, excipients of desvenlafaxine
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
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 in the 60 days preceding the study.
Volunteers 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