Who is sponsoring NCT02233972?

NCT02233972 is sponsored by Jiangsu Kanion Pharmaceutical Co., Ltd.

What condition does NCT02233972 study?

NCT02233972 studies Pharmacokinetics.

What drugs are being tested in NCT02233972?

Interventions: Midazolam, Ginkgolides Meglumine Injection, placebo.

What is the status of NCT02233972?

NCT02233972 is currently COMPLETED.

Last reviewed 2014-10-16 · How we verify

A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam.

NCT02233972 Phase 4 COMPLETED

This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.

Details

Lead sponsor	Jiangsu Kanion Pharmaceutical Co., Ltd
Phase	Phase 4
Status	COMPLETED
Enrolment	15
Start date	2014-08

Conditions

Pharmacokinetics

Interventions

Midazolam
Ginkgolides Meglumine Injection
placebo

Primary outcomes

Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam. — Day 1 and Day 22
Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam. — Day 1 and Day 22
Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection. — Day 8
Pharmacokinetics parameters：T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection. — Day 19 and Day22
Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection. — Day 19

Countries

China