Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001407381
Ethics application status
Approved
Date submitted
3/10/2017
Date registered
4/10/2017
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a test formulation of 1 x 30 mg isotretinoin capsule against the innovator 1 x 30 mg isotretinoin capsules conducted under fasting conditions in healthy male volunteers.
Scientific title
A single dose, randomized, open-label, pharmacokinetic study of a test formulation of 1 x 30 mg isotretinoin capsule in a 2 way crossover comparison against the innovator 1 x 30 mg isotretinoin capsules conducted under fasting conditions in healthy male volunteers.
Secondary ID [1] 293044 0
None
Universal Trial Number (UTN)
U1111-1201-4598
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Isotretinoin is a medicine that is used to treat severe forms of acne. 304948 0
Condition category
Condition code
Skin 304276 304276 0 0
Dermatological 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 30 mg capsule on one occasion and the innovator formulation of isotretinoin, 1 x 30 mg capsules 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 dosing 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.
Intervention code [1] 299269 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study whereby each participant receives the test formulation of isotretinoin (1 x 30 mg) on one occasion and the innovator formulation of isotretinoin (1 x 30 mg) on one occasion with each dose separated by a two week washout period. The comparator/control for this trial is the innovator formulation of isotretinoin.
Control group
Active

Outcomes
Primary outcome [1] 303551 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] 303551 0
-10, -2, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 36, 48, 60 and 72 hours post dosing.
Secondary outcome [1] 339338 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] 339338 0
-10, -2, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 16, 20, 24, 36, 48, 60 and 72 hours post dosing.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Females
History of recent recurrent attacks of bronchitis, asthma or migraine headaches
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 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
Contact lens wearers and individuals who have very fair skin and a strong propensity to sunburn
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.
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. Randomization will be performed using a randomisation table created by computer software (i.e. computerized sequence generation).
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
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/10/2017
Actual
10/10/2017
Date of last participant enrolment
Anticipated
Actual
17/11/2017
Date of last data collection
Anticipated
Actual
12/12/2017
Sample size
Target
36
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 9253 0
New Zealand
State/province [1] 9253 0
Otago

Funding & Sponsors
Funding source category [1] 297658 0
Commercial sector/Industry
Name [1] 297658 0
Douglas Pharmaceuticals Ltd
Country [1] 297658 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
PO Box 1777
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 296686 0
None
Name [1] 296686 0
Address [1] 296686 0
Country [1] 296686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298741 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 298741 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 298741 0
New Zealand
Date submitted for ethics approval [1] 298741 0
30/08/2017
Approval date [1] 298741 0
03/10/2017
Ethics approval number [1] 298741 0
17/STH/166

Summary
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 fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78078 0
Dr Noelyn Hung
Address 78078 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 78078 0
New Zealand
Phone 78078 0
+64345779669
Fax 78078 0
+6434779605
Email 78078 0
[email protected]
Contact person for public queries
Name 78079 0
Linda Folland
Address 78079 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 78079 0
New Zealand
Phone 78079 0
+6434779669
Fax 78079 0
+6434779605
Email 78079 0
[email protected]
Contact person for scientific queries
Name 78080 0
Tak Hung
Address 78080 0
Zenith Technology Corp Ltd
PO Box 1777,
Dunedin 9054
Country 78080 0
New Zealand
Phone 78080 0
+6434779669
Fax 78080 0
+6434779605
Email 78080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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