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Trial registered on ANZCTR


Registration number
ACTRN12611000552987
Ethics application status
Approved
Date submitted
26/05/2011
Date registered
31/05/2011
Date last updated
3/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetic Study of the Modern Chinese Medicine Dantonic in a healthy Western Population
Scientific title
Pharmacokinetic Study of the Modern Chinese Medicine “Dantonic” (Registered Trademark) (T89) in a healthy Western Population
Secondary ID [1] 262277 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy adults 267960 0
Condition category
Condition code
Alternative and Complementary Medicine 268097 268097 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) name: Dantonic (coded as T89)
b) dose administered: 1 gram (4 capsules) per time
c) mode administered: oral capsule

This is a multiple-dose study in four groups (6 cases each):
Group A: oral taking T89, 4 capsules per time, twice per day for one day: Group B: oral taking T89, 4 capsules per time, twice per day for 2 days; Group C: oral taking T89, 4 capsules per time, twice per day for 3 days; and Group D: oral taking T89, 4 capsules per time, twice per day for 4 days.
Intervention code [1] 266655 0
Treatment: Drugs
Comparator / control treatment
no control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 266842 0
For pharmacokinetics, assessment of the levels of the major chemical compounds in this herbal medicine in the blood and urine samples of the testing people, by using a HPLC technique at the Monash research lab
Timepoint [1] 266842 0
at 0, 5min, 10min, 15min, 25min, 35min, 45min, 1.25hrs, 2hrs, 3hrs, 4hrs, 6hrs, and 8hrs in the 1st, 2nd, 3rd, and 4th day following T89 therapy
Secondary outcome [1] 276488 0
for the safety and side effects (e.g. possible changes in ECG, full blood count, and liver and kidney function), at the Monash department to record ECG and at the Alfred hospital pathological lab to determine blood cells, Bilirubin, ALT, AST, Urea, and Creatinine
Timepoint [1] 276488 0
at before and at 24 hours, 48 hours, 3 days, and 4 days after completion of T89 therapy

Eligibility
Key inclusion criteria
1. Healthy subjects of non-Asian background;
2. Aged from 18 to 50 years, either male or female (adjusted to ensure similar numbers between sexes in each group);
3. Body Mass Index (BMI) between 19.0 and 30.0;
4. Healthy physical condition, without significant active disease of the heart, lung, or other organs;
5. Satisfactory test results of liver and kidney function, blood and urine testing; and
6. Signed informed consent
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinically significant cardio-cerebral disease, organic disease of the haematological, nervous and other systems;
2. Pregnant or nursing mother - Women of childbearing potential must have a negative pregnancy test, not be breast feeding and be established on a method of contraception that in the investigator’s opinion is acceptable;
3. On-going other treatment or medicine that may interfere with the actions of T89 or administration of similar medication within 2 weeks of entering study;
4. Blood donor in recent 3 months;
5. Have taken part in other clinical trials involving administration of study medications in the previous 3 months;
6. Excessive alcohol use; or
7. Known hypersensitivity to any of the ingredients of T89 or other relevant drug allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Parallel
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 in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1199 0
The Alfred - Prahran
Recruitment postcode(s) [1] 7061 0
3181 - Prahran East

Funding & Sponsors
Funding source category [1] 267143 0
Commercial sector/Industry
Name [1] 267143 0
Industry Research and Tasly R&D Funds
Address [1] 267143 0
Tasly R&D Institute, 2 Pujihe East Road, Baichen District, Tianjin 300410, P.R. China
Country [1] 267143 0
China
Funding source category [2] 267161 0
Government body
Name [2] 267161 0
National Department of Sciences and Technology
Address [2] 267161 0
54 Shan Li He Road, P.O. Box 2143, Division of International Collaboration, Department of Sciences & Technology, Beijing 100045, P.R. China
Country [2] 267161 0
China
Primary sponsor type
Government body
Name
National Department of Sciences and Technology
Address
54 Shan Li He Road, P.O. Box 2143, Division of International Collaboration, Department of Sciences & Technology, Beijing 100045, P.R. China
Country
China
Secondary sponsor category [1] 266216 0
Commercial sector/Industry
Name [1] 266216 0
Tasly Pharmaceutical Co., Ltd.
Address [1] 266216 0
2 Pujihe East Road, Baichen District, Tianjin 300410, P.R. China
Country [1] 266216 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269132 0
The Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 269132 0
Alfred Hospital, Commercial Road, Prahran, Vic 3181
Ethics committee country [1] 269132 0
Australia
Date submitted for ethics approval [1] 269132 0
01/06/2011
Approval date [1] 269132 0
Ethics approval number [1] 269132 0
Project215-11

Summary
Brief summary
This study aims to examine the pharmacokinetics of herbal medicine T89 in healthy western adults. Based on the similar study in Chinese people, it is hypothesised that following an oral administration, T89 will be detectable in the circulation at ~15 minutes, peaked at 60 minutes to 2 hours, significantly reduced at 6 to 8 hours, and undetectable after 12 hours. It is removed from the body through the urine, which starts at ~2 hours and completes within 24 hours following the administration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32665 0
Prof Paul Komesaroff
Address 32665 0
The Alfred Centre, 99 Commercial Road, Prahran, Victoria 3181
Country 32665 0
Australia
Phone 32665 0
61 3 9903 0622
Fax 32665 0
Email 32665 0
paul.komesaroff@monash.edu
Contact person for public queries
Name 15912 0
Prof Paul Komesaroff
Address 15912 0
The Alfred Centre, 99 Commercial Road, Prahran, Vic 3181
Country 15912 0
Australia
Phone 15912 0
61 3 9903 0622
Fax 15912 0
61 3 9903 0018
Email 15912 0
paul.komesaroff@monash.edu
Contact person for scientific queries
Name 6840 0
Dr Shanhong Ling
Address 6840 0
The Alfred Centre, 99 Commercial Road, Prahran, Vic 3181
Country 6840 0
Australia
Phone 6840 0
61 3 9903 0615
Fax 6840 0
61 3 9903 0018
Email 6840 0
shanhong.ling@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary