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Clinical trial for evaluation of the breviscapine affect to cytochrome P450 enzymes and transporter in healthy volunteers

To study the effects and mechanism of breviscapine on cytochrome P450 enzymes and drug protein transporter activity

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-16009366
Enrollment
Unknown
Registered
2016-10-10
Start date
2016-10-10
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

Healthy

Interventions

Placebo:40mg po tid of placebo for two week, on the 15th day a single dose of fexofenadine120mg or midazolam 7.5mg or losartan potassium 50mg is given to volunteers
Breviscapine:40mg po tid of breviscapine for two week, on the 15th day a single dose of fexofenadine120mg or midazolam 7.5mg or losartan potassium 50mg is given to volunteers

Sponsors

College of Pharmacy and Chemistry, Dali University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Healthy subjects aged 18 and 30 years; 2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 45 kg; 3. Without major disease history and history of drug allergy; 4. Non-drug,smoke and alcohol abuser; 5. All volunteers were not allowed to take any medications 2 wk before the study period; 6. Volunteers can communicate well with investigator and obey the rules of the study; 7. 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
The plasma concentrations of fexofenadine;The plasma concentrations of losartan and E3174;The plasma concentrations of midazolam and 1-OH midazolam;

Countries

China

Contacts

Public ContactLai Yong

College of Pharmacy and Chemistry, Dali University

laiyong8879@163.com+86 15812192673

Outcome results

None listed

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