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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.
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 heart disease, by the State Food and Drug Administration (SFDA) of China in 1993. There were more than 2 billion doses have been prescribed or used, in about 10,000,000 subjects, in short or long-term administration worldwide.
The product is also marketed, as a drug, in Russia, South Korea, Mongolia, Singapore, Vietnam, and South Africa. The current study is to determine the anti-angina effect and dose response of T89 in patients with chronic stable angina pectoris in the United States.
T89 consists of Danshen (Radix Salviae Miltiorrhizae, RSM) and Sanqi (Radix Notoginseng, RN) as active constitutes, and using Borneol as transporting enhancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T89 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T89(Dantonic) | Drug | capsule, 225mg B.I.D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The PK variables of the cocktail substrates with and without T89. | caffine: AUC(0-12h)&Cmax; Omeprazole:AUC(0-12h)& Cmax; Midazolam:AUC(0-12h)& Cmax; Dextromethorphan:Dextromethorphan/Dextrorphan(12h Urine) S-warfarin: AUC(0-96h)& Cmax; | 25 days (From Day 1 to Day 25) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments (AEs, Vital signs, ECG, Safety labs, INRs) | subjects will be followed for the safety assessment from Day 0 to Day 35. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Zhixin GUO, M.D. | Tasly Pharmaceuticals Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Clinical Development NW Inc. | Tacoma | Washington | 98418 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C581239 | T89 herbal drug |
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |