Comparative assessment in healthy male volunteers under fasting conditions of the absorption and pharmacokinetics of 3 generic formulations of isotretinoin capsules against the innovator isotretinoin capsule in a pilot study

This clinical trial, "Comparative assessment in healthy male volunteers under fasting conditions of the absorption and how the body processes the drugs of 3 generic formulations of isotretinoin capsules against the innovator isotretinoin capsule in a pilot study," is a research study looking for volunteers to participate. The study is looking for participants who are at least 18 years old and no older than 55 years. This study is only for male participants. The goal of this study is to help researchers learn more about potential treatments and improve patient care. You may be eligible if: - Healthy males - Aged between 18 and 55 years - Non-smoker - BMI greater than or equal to 19 and less than 30 inclusive - Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests - Drug free as determined by urine drug testing - Able to comply with the study restrictions - Able to provide written information consent - You are at least 18 years old and no older than 55 years You may NOT be eligible if: - Females - Concomitant drug therapy of any kind - History of depression or other mental illness, or a history of epilepsy or seizures - History of conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug - History of alcohol or drug abuse or dependency - Sensitivities to Vitamin A or food such as liver - Participation in a drug study within 60 days of the start of the study or undertaking to donate blood within 60 days after the completion of the study - Sensitivities to isotretinoin, its excipients or any other retinoids - Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk Talk to your doctor to see if this trial is right for you.