Comparative assessment of the absorption of a generic formulation of alpha,alpha-dimethylphenethylamine tablet against the innovator alpha,alpha-dimethylphenethylamine capsule conducted under fasting conditions and at steady state in healthy male and female volunteers.
- Conditions
- alpha,alpha-dimethylphenethylamine is a C5 Controlled Drug indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regime of weight reduction.Diet and Nutrition - Obesity
- Registration Number
- ACTRN12617001321336
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Healthy males and Females
Aged between 18 and 55
Non-smoker
BMI between 18 and 30
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
History of psychiatric illness including anorexia nervosa and depression
Females who are pregnant or breast-feeding
Sensitivity to the study drug or its ingredients
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 alpha,alpha-dimethylphenethylamine (as summarised by Cmax(ss) and AUC(ss)) for the two formulations. All plasma samples will be assayed for alpha,alpha-dimethylphenethylamine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[ Immediately prior to dosing on study days 1-4 and 15-18 and at 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20 and 24 hours post dosing. ]
- 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 alpha,alpha-dimethylphenethylamine using a fully validated LC/MS/MS method.[ Immediately prior to dosing on study days 1-4 and 15-18 and at 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20 and 24 hours post dosing. ]