Comparative assessment of the absorption of a generic formulation of phentermine capsule against the innovator phentermine capsule conducted under fed conditions in healthy male and female volunteers in a pilot study
- Conditions
- Bioequivalence pilot study conducted in healthy volunteers comparing two formulations of phentermine 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, phentermine 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.Bioequivalence pilot study conducted in healthy volunteers comparing two formulations of phentermine 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, phentermine 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
- ACTRN12617000172303
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 13
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18 and 30 inclusive
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 (in particular monoamine oxidase inhibitors)
Sensitivity to phentermine or any other similar class of medicines, or the excipients of phentermine
Any history of psychiatric illness including anorexia nervosa and depression
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are 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 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 phentermine (as summarised by Cmax and AUC) for the formulation. All plasma samples will be assayed for phentermine using one 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 Time 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]