None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 30 mg isotretinoin capsule relative to that of the reference formulation (innovator brand of 30 mg isotreinoin capsule) following oral administration of a single dose of 30 mg in healthy male subjects under fed conditions.
Interventions
Single dose, crossover study design whereby each participant receives the test formulation of isotretinoin, 1 x 30 mg capsule on one occasion and the innovator formulation of isotretinoin, 1 x 30 mg capsule on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test formulation of isotretinoin.
No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose).
Participants are required
Single dose, crossover study design whereby each participant receives the test formulation of isotretinoin, 1 x 30 mg capsule on one occasion and the innovator formulation of isotretinoin, 1 x 30 mg capsule on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test formulation of isotretinoin. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the water consumed with each dose). Participants are required not to eat for 10 hours before receiving a standardised high fat content meal and to fast for approximately 4 hours after each dose. Bathroom visits will be supervised to ensure no unauthorized water or food intake and for personal safety. Participants will be confined at the Clinical Site for 12 hours prior to dosing to ensure compliance and for 24 hours after dosing. Participants will be monitored for adverse events throughout the study. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 12 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of the participants along with HIV, Hepatitis and drugs of abuse testing. Each dose will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure that the medication has been taken as directed.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy males Aged between 18 and 55 years Non-smoker BMI greater than or equal to 18.5 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 informed consent
Exclusion criteria
Females Concomitant drug therapy of any kind Received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study 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 30 days of the start of the study Sensitivities to alitretinoin, its excipients or any other retinoids Individuals for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
Outcome results
None listed