Status:
COMPLETED
A Study To Evaluate The Effect of T89(Dantonic®)On P450 Enzymes
Lead Sponsor:
Tasly Pharmaceuticals, Inc.
Conditions:
Stable Angina
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Purpose: This study is to determine the effect of T89(Dantonic®)on P450 enzymes. This study will help determine which types of drugs may interact with T89.
Detailed Description
T89 is a modernized and industrialized version of a traditional Chinese herbal medicine. T89 was approved for marketing as a drug, for the treatment of chronic stable angina pectoris due to coronary h...
Eligibility Criteria
Inclusion
- Nonsmoking Male or female 18-50 years of age, with a body mass index (BMI)18 to ≤ 30 kg/m2
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations;
- Avoid eating Seville oranges, grapefruits (including grapefruit juice), broccoli, brussels sprouts, charcoal-grilled meats, alcoholic beverages, and caffeine- and theobromine-containing beverages and foods for the duration of the study beginning at the screening visit.
- Females of child bearing potential must be able to maintain adequate birth control during the study; defined as double barrier method or complete abstinence. Females of non-child bearing potential must provide documentation of tubal ligation or hysterectomy.
- Be able to provide written informed consent and comply with requirements of the study;
- Be able to read, speak and understand English
Exclusion
- Clinically significant abnormal findings by history, physical exam, ECG, or laboratory testing as determined by the study doctor.
- Know hypersensitivity or intolerance to any of the probe substrates or the active and/or inactive ingredients in the probe substrates, flumazenil, guaifenesin, or vitamin K;
- A history of illicit drug use or a history of alcohol abuse within 1 year of screening.
- Women who are pregnant, breastfeeding, and/or not using an acceptable form of non-hormonal contraception (double barrier method or abstinence) during the study.
- History of gastrointestinal bleeding or peptic ulcer disease.
- Any condition that may affect drug absorption (e.g., gastrectomy, malabsorption syndromes).
- Had an elevated international normalized ratio (INR) time (INR\> 1.2) at screening or Day-1.
- Had taken any nicotine-containing or nicotine replacement devices within 6 months before the screening visit
- Had taken any prescription drugs during the 3 months before the screening visit
- Had taken any nonprescription drugs (including natural health products, Vitamins, and herbals) during a period of 7 days prior to the screening visit
- Had received an immunization during the 2 weeks prior to the screening visit
- Had known immune deficiency disease or were positive for human immunodeficiency virus, Hepatitis B or Hepatitis C virus.
- Use of any drug known to inhibit or induce hepatic enzymes within 30 days of the first study phase.
- Regular alcohol intake exceeding 1 drink/day (1 drink = 5 ounces of wine or 12 ounces of beer or 1 ounce of hard liquor) within 7 days of screening.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study drug.
- Presence of any condition that the investigator feels would interfere with successful completion of the study.
- Genotyping of poor metabolizers for CYP2D6, CYP2C9, and CYP2C19.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01473888
Start Date
January 1 2011
End Date
January 1 2012
Last Update
November 8 2012
Active Locations (1)
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1
Comprehensive Clinical Development NW Inc.
Tacoma, Washington, United States, 98418