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Trial registered on ANZCTR


Registration number
ACTRN12616000663459
Ethics application status
Approved
Date submitted
18/05/2016
Date registered
23/05/2016
Date last updated
30/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 289248 0
None
Universal Trial Number (UTN)
U111-1181-8907
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acne 298824 0
Condition category
Condition code
Skin 298883 298883 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294790 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation of isotretinoin (1 x 10 mg) on one occasion and the innovator formulation of isotretinoin (1 x 10 mg) on one occasion with each dose separated by a one week washout period. The comparator/control for this trial is the innovator formulation of isotretinoin.
Control group
Active

Outcomes
Primary outcome [1] 298349 0
To evaluate the pharmacokinetics (as summarised by Cmax and AUC) of the test formulation relative to that of the reference formulation. All plasma samples will be assayed for isotretinoin using one fully validated LC/MS/MS method. Validation will be conducted to comply with FDA guidelines.
Timepoint [1] 298349 0
-10, -2, -1, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0, 48.0, 56.0 and 72 hours after dosing.
Secondary outcome [1] 323906 0
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.
Timepoint [1] 323906 0
-10, -2, -1, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 9.0, 10.0, 12.0, 16.0, 20.0, 24.0, 32.0, 48.0, 56.0 and 72 hours after dosing.

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All formulations will be labeled as Formulation A and B.. The identification of each treatment will only be known to the Managing Director and Section Head - Trials and Regulatory Affairs or their delegate. Randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit study number (randomisation number) after acceptance into the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/06/2016
Actual
21/07/2016
Date of last participant enrolment
Anticipated
Actual
27/07/2016
Date of last data collection
Anticipated
Actual
9/08/2016
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 7884 0
New Zealand
State/province [1] 7884 0
Otago

Funding & Sponsors
Funding source category [1] 293623 0
Commercial sector/Industry
Name [1] 293623 0
Douglas America Ltd
Country [1] 293623 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 292454 0
None
Name [1] 292454 0
Address [1] 292454 0
Country [1] 292454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295061 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 295061 0
Ethics committee country [1] 295061 0
New Zealand
Date submitted for ethics approval [1] 295061 0
13/04/2016
Approval date [1] 295061 0
06/05/2016
Ethics approval number [1] 295061 0
16/CEN/51

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65962 0
Dr Noelyn Hung
Address 65962 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 65962 0
New Zealand
Phone 65962 0
+6434779669
Fax 65962 0
+6434779605
Email 65962 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 65963 0
Linda Folland
Address 65963 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 65963 0
New Zealand
Phone 65963 0
+6434779669
Fax 65963 0
+6434779605
Email 65963 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 65964 0
Cheung-Tak Hung
Address 65964 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 65964 0
New Zealand
Phone 65964 0
+6434779669
Fax 65964 0
+6434779605
Email 65964 0
tak.hung@zenithtechnology.co.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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