Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects

PHASE1UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

October 31, 2016

Study Completion Date

November 30, 2016

Conditions
Healthy
Interventions
DRUG

Mianhuahua Flavonoids Tablets

"Tolerability Study:~Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(seven dose groups:0.3g-5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD(maximum tolerated dose)/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID)~Pharmacokinetic Study:~Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(six dose groups: 0.9g, 1.8g, 2.7g, 3.6g, 4.5g, 5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD(maximum tolerated dose)/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID)"

DRUG

Placebo

Placebo to match with experimental groups

Sponsors
All Listed Sponsors
collaborator

Chinese Academy of Sciences

OTHER_GOV

lead

Xinjiang Uygur Pharmaceutical Co., Ltd.

INDUSTRY

NCT02622230 - Tolerability, Safety and Pharmacokinetic Study Of Mianhuahua Flavonoids Tablets in Healthy Adult Subjects | Biotech Hunter | Biotech Hunter