Comparative assessment of the absorption of a generic formulation of 2-methyl-1-phenylpropan-2-amine (122-09-8) 15 mg capsule against the innovator 2-methyl-1-phenylpropan-2-amine (122-09-8) 15 mg capsule conducted under fasting condition in healthy male and female volunteers.
- Conditions
- 2-methyl-1-phenylpropan-2-amine (122-09-8) 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
- ACTRN12617001510336
- Lead Sponsor
- Zenith Technology Corporation Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
Healthy males and non-pregnant female volunteers.
Aged between 18 and 55
Non-smoker
BMI between 18.5 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
Any history of heart problems
Sensitivity to the study drug
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
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
Volunteers for whom the Clinical Investigator believer, 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 2-methyl-1-phenylpropan-2-amine (122-09-8) (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for 2-methyl-1-phenylpropan-2-amine (122-09-8) using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines.[ 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20, 24, 32, 48, 56 and 72 hours post dosing.]
- Secondary Outcome Measures
Name Time Method The to maximum peak concentration (Tmax) will be determined by plasma sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.[ 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 20, 24, 32, 48, 56 and 72 hours post dosing.]