Comparative assessment in healthy male volunteers under fasting conditions of the absorption and pharmacokinetics of a test formulation of isotretinoin capsule against an innovator isotretinoin capsule in a pilot study
A single dose, randomized, blinded, 2 way crossover pilot pharmacokinetic study of 1 test formulation of isotretinoin capsule against the innovator isotretinoin capsule conducted under fasting conditions in healthy male volunteers
Zenith Technology Corporation Limited
16 participants
Jul 21, 2016
Interventional
Conditions
Summary
The objective of this study is to evaluate the pharmacokinetics of one test formulation of isotretinoin 10 mg capsule against the reference formulation (innovator brand of 10 mg isotretinoin capsule) following administration of a single oral dose in healthy male subjects under fasting conditions.
Eligibility
Inclusion Criteria8
- 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
Exclusion Criteria9
- 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
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Interventions
Single dose, crossover study design whereby each participant receives the test formulation of isotretinoin, 1 x 10 mg capsule on one occasion and the innovator formulation of isotretinoin, 1 x 10 mg capsule on one occasion. 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 each dose 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. Each dose is separated by a one week washout period.
Locations(1)
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ACTRN12616000663459