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
- 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
- ACTRN12615000832572
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 22
Healthy males and Females
Aged between 18 and 55
Non-smoker
BMI between 18 and 33
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent
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
- Primary Outcome Measures
Name Time Method To compare the bioavailability of desvenlafaxine (as summarised by Cmax and AUC) for the two formulations. All plasma samples will be assayed for desvenlafaxine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 20, 24, 32, 48, 56 and 72 hours]
- Secondary Outcome Measures
Name Time Method Time to maximum peak concentration (Tmax). Tmax will be the time where the maximum concentration occurred in the sample points. All plasma samples will be assayed for desvenlafaxine using a fully validated LC/MS/MS method.[0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 20, 24, 32, 48, 56 and 72 hours];The elimination half life (t1/2). T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. All plasma samples will be assayed for desvenlafaxine using a fully validated LC/MS/MS method.[0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 11, 12, 16, 20, 24, 32, 48, 56 and 72 hours]