PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial
Ключови думи
Резюме
Описание
With the greatly increased morbidity of neck pain, it brought a large challenge to some optimal therapies for various situations in population at a given time based on their demographic, physiological and pathological characteristics. Chinese proprietary herbal medicines, as a kind of Complementary and Alternative Medicine (CAM), are usually developed from some well-established and long-standing recipes and formulated as tablets or capsules for commerce, convenience or palatability. Although these advantage mentioned, a good quantification and a strict standardization in detail are still need to be improved for individualized implementation in therapeutic strategies. Based on the YQHY decoction (Yi-Qi Hua-Yu Decoction, tonify Qi and promoting circulation and removing stasis), Qishe Pill (Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) has been developed and spread in use into clinical settings in 2009. As individualization has become the trend of modern medicine, a personalized medicine of Qishe Pill should be documented and practiced with various patients according to the ancient TCM system, a classification of personalized constitution type, which has been established to determine predisposition and prognosis to diseases as well as therapy and life-style administration. Therefore, we describe the population pharmacokinetic profile of Qishe Pill and compare its extent of metabolism in the 3 major Constitution Type (Qi-Deficiency, Yin-Deficiency and Blood-Stasis) to address major challenges of individualized and standardized Traditional Chinese Medicine into clinical practice.
Дати
| Последна проверка: | 10/31/2014 |
| Първо изпратено: | 09/10/2014 |
| Очаквано записване подадено: | 11/14/2014 |
| Първо публикувано: | 11/18/2014 |
| Изпратена последна актуализация: | 11/14/2014 |
| Последна актуализация публикувана: | 11/18/2014 |
| Действителна начална дата на проучването: | 10/31/2014 |
| Приблизителна дата на първично завършване: | 11/30/2015 |
| Очаквана дата на завършване на проучването: | 06/30/2016 |
Състояние или заболяване
Интервенция / лечение
Drug: Qishe Pill
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: cohort 1 Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg) | |
| Experimental: cohort 2 Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg) | |
| Experimental: cohort 3 Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg) |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 20 Years Да се 20 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion - Aged 20-35 - 18.5 kg/m2 ≤Body mass index (BMI) <23 kg/m2 - TCM-constitutionally typed as either the 3 major type Exclusion - History of impaired fasting glucose or diabetes mellitus (past history of diabetes or fasting blood glucose at screening ≥100 mg/dl) - History of liver disease (hepatitis, hepatic cirrhosis) or hepatic dysfunction (AST or ALT at screening ≥40 U/L) - History of renal dysfunction (creatinine at screening ≥1.2 mg/dl) - History of heart disease (heart failure, angina pectoris, myocardial infarction, arrhythmia) - History of malignant tumor - Having digestive disorders that can interfere with normal absorption of standard diet (gastritis, gastric ulcer, duodenitis, duodenal ulcer, etc.) - Smoking during the recent 3 months - Alcohol consumption 3 or more times a week during the recent 3 months - Women who were pregnant, intended to become pregnant, or breast- feeding - Medicated during the recent month for therapeutic or prophylactic purposes - Participating in another clinical trial |
Резултат
Първични изходни мерки
1. Plasma concentration of Qishe Pill [Dosing(0 hour)]
2. Plasma concentration of Qishe Pill [15 min after dosing]
3. Plasma concentration of Qishe Pill [30 min after dosing]
4. Plasma concentration of Qishe Pill [45 min after dosing]
5. Plasma concentration of Qishe Pill [60 min after dosing]
6. Plasma concentration of Qishe Pill [90 min after dosing]
7. Plasma concentration of Qishe Pill [120 min after dosing]
8. Plasma concentration of Qishe Pill [150 min after dosing]
9. Plasma concentration of Qishe Pill [180 min after dosing]
10. Plasma concentration of Qishe Pill [240 min after dosing]
11. Plasma concentration of Qishe Pill [360 min after dosing]
12. Plasma concentration of Qishe Pill [480 min after dosing]
13. Plasma concentration of Qishe Pill [600 min after dosing]
14. Plasma concentration of Qishe Pill [720 min after dosing]
15. Plasma concentrations of Qishe Pill [1440 min after dosing]
16. Plasma concentration of Qishe Pill [2160 min after dosing]
17. Plasma sampling of Qishe Pill for pharmacokinetic analysis [2880 min after dosing]
18. Vital signs [Dosing(0 hour)]
19. Vital signs [180 min after dosing]
20. Vital signs [720 min after dosing]
21. Vital signs [1440 min after dosing]
22. Vital signs [2160 min after dosing]
23. Vital signs [2880 min after dosing]
24. ECG monitoring [Dosing(0 hour)]
25. ECG monitoring [180 min after dosing]
26. ECG monitoring [720 min after dosing]
27. ECG monitoring [1440 min after dosing]
28. ECG monitoring [2160 min after dosing]
29. ECG monitoring [2880 min after dosing]
30. Number of Participants with Adverse Events [Day 1 of drug administration and blood sampling]
31. Number of Participants with Adverse Events [Day 2 of drug administration and blood sampling]
32. Number of Participants with Adverse Events [Day 3 of drug administration and blood sampling]
33. Number of Participants with Adverse Events [4 days after drug administration and blood sampling]
34. Peak Plasma Concentration (Cmax) of Qishe Pill in low dosage [4 days after drug administration and blood sampling]
35. Peak Plasma Concentration (Cmax) of Qishe Pill in medial dosage [4 days after drug administration and blood sampling]
36. Peak Plasma Concentration (Cmax) of Qishe Pill in high dosage [4 days after drug administration and blood sampling]
37. The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in low dosage [4 days after drug administration and blood sampling]
38. The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in medial dosage [4 days after drug administration and blood sampling]
39. The Time to Peak Plasma Concentration (Tmax) of Qishe Pill in high dosage [4 days after drug administration and blood sampling]
40. Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in low dosage [4 days after drug administration and blood sampling]
41. Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in medial dosage [4 days after drug administration and blood sampling]
42. Area under the Plasma Concentration versus Time Curve (AUC) of Qishe Pill in high dosage [4 days after drug administration and blood sampling]
43. The distribution volume (DF) of Qishe Pill in low dosage [4 days after drug administration and blood sampling]
44. The distribution volume (DF) of Qishe Pill in medial dosage [4 days after drug administration and blood sampling]
45. The distribution volume (DF) of Qishe Pill in high dosage [4 days after drug administration and blood sampling]
Вторични изходни мерки
1. Deep phenotyping with genomics and functional genomics approaches [Dosing(0 hour)]
2. Deep phenotyping with genomics and functional genomics approaches [2880 min after dosing]
Други изходни мерки
1. The Constitution in Chinese Medicine Questionnaire (CCMQ) [During screening in the recuitment]
2. The Constitution in Chinese Medicine Questionnaire (CCMQ) [2880 min after dosing]
3. Laboratory measures and clinical assessment [During screening in the recuitment]
