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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19

Clinicaltrials.gov identifier NCT03942458

Recruitment Status Completed

First Posted May 8, 2019

Last update posted September 19, 2019

Study Description

Brief summary:

This study is a single-center, randomized, open, two-cycle crossover, clopidogrel control, multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior of different metabolites of CYP2C19 in healthy subjects. The study enrolled 48 patients, divided into three groups of CYP2C19 fast metabolite, middle metabolite, and slow metabolism, 16 cases in each group. All groups of subjects were administered for 7 days in the first cycle, once a day (loading dose on the first day, maintenance dose on other days), and entering the 14-day washout period after the end of the first cycle. The second cycle was entered, and the second cycle was administered for 7 days, once a day (the first day was given a loading dose, and the other days were given a maintenance dose). Blood was collected before and after administration of D1, D7, D22, and D28, and PK/PD was measured.

  • Condition or Disease:Healthy Subjects
    PK/PD
  • Intervention/Treatment: Drug: Vicagrel 6mg
    Drug: Clopidogrel 75mg
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 50 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19
  • Actual Study Start Date: April 2019
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: September 2019
Arms and interventions
Arm Intervention/treatment
Experimental: Vicagrel
Vicagrel 24mg loading followed by 6mg/day for 6 days
Drug: Vicagrel 6mg
Vicagrel 24mg loading followed by 6mg/day for 6 days
Active Comparator: Clopidogrel
Clopidogrel 300mg loading followed by 75mg/day for 6 days
Drug: Clopidogrel 75mg
Clopidogrel 300mg loading followed by 75mg/day for 6 days
Outcome Measures
  • Primary Outcome Measures: 1. Peak Plasma Concentration (Cmax) [ Time Frame: 1 day,7 days after taking drugs ]
    To evaluate the Peak Plasma Concentration (Cmax) after taking drugs
  • 2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 1 day,7 days after taking drugs ]
    To evaluate the AUC after taking drugsl
  • 3. Time to maximum plasma concentration (Tmax) [ Time Frame: 1 day,7 days after taking drugs ]
    To evaluate the Tmax after taking drugs
  • 4. terminal half-life (T1/2) [ Time Frame: 1 day,7 days after taking drugs ]
    To evaluate the T1/2 after taking drugs
  • 5. inhibition of platelet aggregation [ Time Frame: 1 day,7 days after taking drugs ]
    To evluate the inhibition of platelet aggregation assessed by Verifynow System after taking drugs
Eligibility Criteria
  • Ages Eligible for Study: 18 to 45 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- Voluntary signing of informed consent before the trial, and full understanding of the
experimental content, process and possible adverse reactions;

- Subjects with ability and adherence to trial protocol;

- Subjects (including partners) voluntarily take effective contraceptive measures from
screening to the last study drug administration within 6 months;

- Male and female aged 18-45,gender is unlimited (including 18 and 45 years old);

- Male Weight ≥50 kg, female Weight ≥ 45 kg, and BMI ranging from 18 to 28 kg/m2
(including critical values);

- Physical examination, normal or abnormal vital signs have no clinical significance
(reference range of vital signs: systolic blood pressure 90-150 mmHg, diastolic blood
pressure 50-95 mmHg, pulse 50-110 beats/min, body temperature 35.5-37.2 °C);

- CYP2C19 rapid metabolizers (CYP2C19*1/*1), or intermediate metabolizers (CYP2C19*1/*2,
CYP2C19*1/*3), or poor metabolizers (CYP2C19*2/*2, CYP2C19*2/* 3, CYP2C19*3/*3).

Exclusion Criteria:

- More than 5 cigarettes per day 3 months before the trial;

- History of allergies or allergies to the drug (two or more drugs or food allergies);

- History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of
beer, or 25 mL of spirits, or 100 mL of wine);

- Donate blood or massive blood loss (> 450 mL) within 3 months prior to formal
screening;

- Take any drug that alters the activity of CYP450s within 28 days before the formal
screening;

- Take any prescription, non-prescription, any vitamin or herbal medicine within 14 days
of the formal screening;

- Take special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks
before the formal screening, or have strenuous exercise, or other factors affecting
drug absorption, distribution, metabolism, excretion, etc.;

- Taking inhibitors or inducers of the CYP3A4, P-gp or Bcrp Currently, such as
itraconazole, ketoconazole or dronedarone;

- Recently there have been major changes in diet or exercise habits;

- Taking other research drugs or participating in clinical trials within 3 months before
taking the study drug;

- History of dysphagia or any gastrointestinal disease affecting drug absorption;

- Have any disease that increases the risk of bleeding, such as acute gastritis, stomach
and duodenal ulcers, thrombocytopenic purpura, hemophilia, and so on;

- ECG abnormalities have clinical significance;

- Female subjects are in lactation or have a positive of pregnancy test;

- Clinical laboratory abnormalities have clinical significance or other clinically
significant abnormalities (including but not limited to gastrointestinal, kidney,
liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and
cerebrovascular diseases);

- Infectious diseases (two pairs of hepatitis B, hepatitis C antibodies, HIV, Treponema
pallidum antibodies) have positive results;

- Acute disease or concomitant medication from the screening to the study;

- Taking chocolate, any food or drink with caffeine or jaundice-rich within 48 hours
before taking the study drug;

- Any alcoholic product or alcohol breath test positive within 24 hours before taking
the study drug;

- Urine drug test (morphine, marijuana) is positive;

- The investigator believes that there are other factors who are not suitable for
participating in the test.

Contacts and Locations
Contacts
Locations

China, Jilin
The First Hospital of Jilin University
Chang chun

Sponsors and Collaborators

Jiangsu vcare pharmaceutical technology co., LTD

More Information
  • Responsible Party: Jiangsu vcare pharmaceutical technology co., LTD
  • ClinicalTrials.gov Identifier: NCT03942458 History of Changes
  • Other Study ID Numbers: VCP1-Ⅰ-04
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: September 19, 2019
  • Last Verified: March 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No