NCT04230057|Unknown
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Sponsor study identifier
observational
12
1 country
1
Study Start
December 12, 2019
Actual (reported)Primary Completion
January 21, 2020
Actual (reported)Study Completion
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to evaluate the single-dose oral pharmacokinetics of an herbal supplement - Antitumor B - in healthy subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2019
Actual (reported)January 11, 2020
Actual (reported)January 18, 2020
Actual (reported)January 21, 2020
Actual (reported)August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cmax of matrine, dictamnine, maackiain and fraxinellone in plasma
Maximum (peak) observed drug concentration in plasma
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose
Cmax of matrine, dictamnine, maackiain and fraxinellone in saliva
Maximum (peak) observed drug concentration in saiva
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose
Tmax of matrine, dictamnine, maackiain and fraxinellone in plasma
Time of Maximum (peak) observed drug concentration in plasma
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose
Tmax of matrine, dictamnine, maackiain and fraxinellone in saliva
Time of Maximum (peak) observed drug concentration in saliva
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose
AUC0-24 of matrine, dictamnine, maackiain and fraxinellone in plasma
Area under the curve of plasma concentration-time profile
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose
Plasma-saliva IVIVC
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose
* In good general health and feeling well (no diagnosed disorders/illnesses) * At least 18 years old * BMI in the range of 18-29.9 kg/m² * No known history of substance abuse * No known allergies to food/drug
Single dose 2400 mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy subjects in University of Houston and nearby area
University of Houston, College of Pharmacy
Houston, Texas, 77204, United States
Lin PZ, Zhang JS, Cao SG, Rong ZP, Gao RQ, Han R, Shu SP. [Secondary prevention of esophageal cancer--intervention on precancerous lesions of the esophagus]. Zhonghua Zhong Liu Za Zhi. 1988 May;10(3):161-6. Chinese.
Lin P, Zhang J, Rong Z, Han R, Xu S, Gao R, Ding Z, Wang J, Feng H, Cao S. Studies on medicamentous inhibitory therapy for esophageal precancerous lesions--3- and 5-year inhibitory effects of antitumor-B, retinamide and riboflavin. Proc Chin Acad Med Sci Peking Union Med Coll. 1990;5(3):121-9.
Blood, Saliva
Ming Hu, PhD
University of Houston
12 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2020
First Posted
January 18, 2020
Study Start
December 12, 2019
Actual (reported)A Study to Explore the Effect of Food Before a Single Dose of Sitravatinib
AUC0-24 of matrine, dictamnine, maackiain and fraxinellone in saliva
Area under the curve of saliva concentration-time profile
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours post dose
Contact the study team to confirm eligibility.
Lin P. [Medicamentous inhibitory therapy of precancerous lesions of the esophagus--3 and 5 year inhibitory effect of antitumor B, retinamide and riboflavin]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 1990 Aug;12(4):235-45. Chinese.
Sun Z, Guan X, Li N, Liu X, Chen X. Chemoprevention of oral cancer in animal models, and effect on leukoplakias in human patients with ZengShengPing, a mixture of medicinal herbs. Oral Oncol. 2010 Feb;46(2):105-10. doi: 10.1016/j.oraloncology.2009.06.004. Epub 2009 Dec 21.
Zhang Z, Wang Y, Yao R, Li J, Yan Y, La Regina M, Lemon WL, Grubbs CJ, Lubet RA, You M. Cancer chemopreventive activity of a mixture of Chinese herbs (antitumor B) in mouse lung tumor models. Oncogene. 2004 May 6;23(21):3841-50. doi: 10.1038/sj.onc.1207496.
Wang Y, Yao R, Gao S, Wen W, Du Y, Szabo E, Hu M, Lubet RA, You M. Chemopreventive effect of a mixture of Chinese Herbs (antitumor B) on chemically induced oral carcinogenesis. Mol Carcinog. 2013 Jan;52(1):49-56. doi: 10.1002/mc.20877. Epub 2011 Nov 15.
Yin T, Yang G, Ma Y, Xu B, Hu M, You M, Gao S. Developing an activity and absorption-based quality control platform for Chinese traditional medicine: Application to Zeng-Sheng-Ping(Antitumor B). J Ethnopharmacol. 2015 Aug 22;172:195-201. doi: 10.1016/j.jep.2015.06.019. Epub 2015 Jun 20.
Gao S, Yang Z, Yin T, You M, Hu M. Validated LC-MS/MS method for the determination of maackiain and its sulfate and glucuronide in blood: application to pharmacokinetic and disposition studies. J Pharm Biomed Anal. 2011 May 15;55(2):288-93. doi: 10.1016/j.jpba.2011.01.015. Epub 2011 Jan 22.
Yang Z, Gao S, Yin T, Kulkarni KH, Teng Y, You M, Hu M. Biopharmaceutical and pharmacokinetic characterization of matrine as determined by a sensitive and robust UPLC-MS/MS method. J Pharm Biomed Anal. 2010 Apr 6;51(5):1120-7. doi: 10.1016/j.jpba.2009.11.020. Epub 2009 Nov 26.
Primary Completion
January 21, 2020
Actual (reported)Study Completion
August 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 27, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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