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Trial registered on ANZCTR


Trial ID
ACTRN12613000538741
Ethics application status
Approved
Date submitted
12/05/2013
Date registered
14/05/2013
Date last updated
28/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Pharmacokinetic Study [the way the body handles drug] of paracetamol and phenylephrine in healthy adults.
Scientific title
Randomised single dose two arm cross-over open label study to determine the bioavailability of a new formulation of paracetamol and phenylephrine tablets [Maxiclear] relative to an oral administration of phenylephrine tablets alone in healthy adults under fasting conditions
Secondary ID [1] 282489 0
NIL
Universal Trial Number (UTN)
Trial acronym
AFT-MXCF-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cold & Flu 289125 0
Condition category
Condition code
Other 289465 289465 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug & Dose: Coadministered Paracetamol 500mg and Phenylephrine 5mg
Dose frequency: Single dose
Duration Administration: Single dose
Mode Administration:Oral tablet
Washout between treatments = 7 days
Intervention code [1] 287141 0
Treatment: Drugs
Comparator / control treatment
Drug & Dose: Phenylephrine 5mg
Dose frequency: Single dose
Duration Administration: Single dose
Mode Administration:Oral tablet
Control group
Active

Outcomes
Primary outcome [1] 289568 0
Evaluation of Pharmacokinetic paramaters [Cmax, AUC, Tmax, T 1/2] of Phenylephrine hydrochloride
Assessed by measurement of plasma drug concentrations
Timepoint [1] 289568 0
Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after study drug administration
Secondary outcome [1] 302748 0
Safety will be evaluated during each study period, and for 7 days following study drug administration.
An acute safety evaluation will be performed during each study period by recording spontaneously reported adverse events and by clinical assessments, including measurements of blood pressure and heart rate.

Known phenylephrine hydrochloride adverse effects (i.e increased systolic and diastolic blood pressure, palpitations, headache, vomiting, nervousness), and known paracetamol adverse effects (i.e. clinical evidence of hepatotoxicity) will be compared between groups.
Adverse events will continue to be assessed up to 7 days after the last dose of the study medication by spontaneous reporting and at a final follow-up phone call.
Timepoint [1] 302748 0
Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after study drug administration
Safety will be evaluated during each study period, and for 7 days following study drug administration.

Eligibility
Key inclusion criteria
Healthy Volunteers
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnancy, nursing, drug abuse, smoking > 10 cigarettes per day, excess alcohol intake, Rx drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5081 0
Jordan
State/province [1] 5081 0

Funding & Sponsors
Funding source category [1] 287272 0
Commercial sector/Industry
Name [1] 287272 0
AFT Pharma
Address [1] 287272 0
Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country [1] 287272 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharma
Address
Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 286025 0
None
Name [1] 286025 0
Address [1] 286025 0
Country [1] 286025 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289252 0
IPRC Institutional Review Board
Ethics committee address [1] 289252 0
172 Queen Rania St
PO Box 963166
Amman 11942
Ethics committee country [1] 289252 0
Jordan
Date submitted for ethics approval [1] 289252 0
16/05/2013
Approval date [1] 289252 0
11/06/2013
Ethics approval number [1] 289252 0

Summary
Brief summary
To measure the pharmacokinetics [how the body treats drugs] of phenylephrine in humans since this is still not well understood and to check this specifically for a tablet mixture of paracetamol and phenylephrin called Maxiclear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39982 0
Prof Abdulla Hiyari
Address 39982 0
International Pharmaceutical Research Center Queen Rania St - Sport City Circle PO Box 963166 Amman 11196
Country 39982 0
Jordan
Phone 39982 0
+962562764/51
Fax 39982 0
+96265627654
Email 39982 0
iprc@iprc.com.jo
Contact person for public queries
Name 39983 0
Dr Hartley Atkinson
Address 39983 0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622


Country 39983 0
New Zealand
Phone 39983 0
+6494880232
Fax 39983 0
+6494880234
Email 39983 0
hartley@aftpharm.com
Contact person for scientific queries
Name 39984 0
Dr Hartley Atkinson
Address 39984 0
AFT Pharmaceutcials td, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country 39984 0
New Zealand
Phone 39984 0
+6494880232
Fax 39984 0
Email 39984 0
hartley@aftpharm.com