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A randomised, placebo-controlled, two-period crossover pharmacokinetic study on modulation of human P-gp by multiple doses of Astragalus root extract granules using fexofenadine as a phenotyping probe

P-glycoprotein related pharmacokinetics study (Astragalus root extract granules as mode)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-12002288
Enrollment
Unknown
Registered
2012-06-23
Start date
2009-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

not disease-related

Interventions

placebo:4g bid for one week, oral ingestion of multiple doses of placebo, a single dose of fexofenadine120mg is given to volunteers and blood samples at different time are collected
Astragalus root extract granules:4g bid for one week, oral ingestion of multiple doses of Astragalus root extract, on the 8th day a single dose of fexofenadine120mg is given to volunteers and blood sa

Sponsors

No. 88, Jiefang Road, Hangzhou, Zhejiang, China
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 25 Years

Inclusion criteria

Inclusion criteria: 1. male healthy subjects; 2. aged 18 to 40y; 3. Body weight (more than 50kg), BMI(19-25kg/m2); 4. without significant medical history and history of drug allergy; 5. non-drug abuser; 6. non-smokers and alcohol abuse; 7. All volunteers were not allowed to take any medications 2 wk before the study period; 8. volunteers can communicate well with investigator and obey the rules of the study; 9. All volunteers gave their written informed consent.

Exclusion criteria

Exclusion criteria: 1. subjects who paticipated in other clinical trials within the past 2 month; 2. subjects who donated blood within the past 1 mo or will donate blood during or after the study; 3. subjects who do not pass the general physical examinations and BP, HR or breath status are not well; 4. subjects who have significant clinical symptoms by physical examination; 5. subjects who have some health problems by electrocardiogram and laboratory tests (including complete blood count, blood biochemistry testing and urinalysis) before starting this study; 6. Invesigator thinks that the subjects are not suitable for participating the clinical trial.

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of fexofendin;

Countries

China

Contacts

Public ContactQuan Zhou
zhouquan142602@zju.edu.cn+86 13588758501

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026