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The effect of St John's Wort on pharmacokinetics and pharmacodynamics of Repaglinide

The effect of St John's Wort on pharmacokinetics and pharmacodynamics of Repaglinide

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000405
Enrollment
Unknown
Registered
2009-05-15
Start date
2009-05-01
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

healthy male

Interventions

experimental group:Repaglinide: 1mg/day
St John's Wort: 325mg 3 times a day*14 days.

Sponsors

Clinical Pharmacology Institute, Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. male; 2. Aged between 18 and 30 years, extremes included; 3. Normal weight as defined by a Quetelet Index (BMI)range of 19.0 - 25.0, extremes included; 4. Non-smokers or occasional smokers (defined as smoking no more than 10 cigarettes per week); 5. Healthy on the basis of a medical history, vital signs, physical examination, electrocardiogram (ECG), and the results of clinical laboratory tests carried out within 1 week prior to the first dosing. 6. Provided signed informed consent prior to beginning protocol-specific procedures, indicating that they understood the purpose of this study and were willing to adhere to the treatment regimen and study procedure described in this protocol; 7. No other drugs were taken within 2 week prior to the first dosing.

Exclusion criteria

Exclusion criteria: 1. History of cardiac arrhythmia, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, parkinsonism, or any other disease or physical condition which could have interfered with the interpretation of the study results; 2. Known significant bleeding diathesis which could have precluded multiple venipunctures; Any gastrointestinal condition that could have affected drug absorption or metabolism; 3. History of drug abuse within past 5 years or positive urine drug screen results; 4. Use of concomitant medication within 14 days before the first dose; Participation in an investigational drug trial within 30 days prior to the first visit or intention to take another investigational drug during the course of the study; 5. Significant loss or donation of blood or plasma (500 mL) within 30 days prior to the start of the study.

Design outcomes

Primary

MeasureTime frame
Indices of pharmacokinetics;Indices of pharmacodynamics;

Countries

China

Contacts

Public ContactLan Fan
fanlan_038038@163.com86 0 15074879138

Outcome results

None listed

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