A Study To Evaluate The Effect of T89(Dantonic®)On P450 Enzymes

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tasly Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.