Comparative assessment of the absorption of a generic formulation of 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule against the innovator 2-methyl-1-phenylpropan-2-amine (122-09-8) capsule conducted under fasting condition and at steady state in healthy male and female volunteers.

Phase 1

Completed

• 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: ACTRN12617001132336
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-02
• Study Completion: 2017-09-24
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

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

Inclusion Criteria

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

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 2-methyl-1-phenylpropan-2-amine (122-09-8), any antidepressant agents, excipients of 2-methyl-1-phenylpropan-2-amine (122-09-8)
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