Pharmacokinetic Study of the Modern Chinese Medicine Dantonic in a healthy Western Population

Pharmacokinetic Study of the Modern Chinese Medicine “Dantonic” (Registered Trademark) (T89) in a healthy Western Population

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000552987

Enrollment

Registered

2011-05-31

Start date

2011-09-09

Completion date

2011-11-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

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

Outcome results