Shijiazhuang Yiling Pharmaceutical Co. Ltd
Shijiazhuang, Hebei, 050035, China
NCT Number: NCT04162275
Design:Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives:
1. To investigate the tolerability and safety of Chinese healthy adult subjects after a single oral administration of Finamine tablets; 2. To investigate the pharmacokinetic (PK) characteristics of Finamine tablets; 3. To provide dose setting basis for follow-up clinical studies. Investigational subject:Healthy-adult subjects in China
34 cases (including 4 cases of the pre- trial), of which the 150mg dose group is in the 4 cases of pre- trial (open, all accepted Finamine tablets orally, among whom, two receive it under fasting condition , and the other two receive it half an hour post a high-fat meal started). There are 6 cases in the formal trial (the subjects' ratio of investigational drug to placebo is 2:1). In all other dose groups, the subjects' ratio of investigational drug to placebo is 3:1.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Shijiazhuang, Hebei, 050035, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
If being one of the following conditions, subjects cannot be selected
taken Finamine tablets orally
Other names: Finamine tablet
taken Placebo tablets orally
Time frame: From 0 to 96 hours after dosing
maximum tolerated dose(MTD)、dose-limiting toxicity(DLT)
Time frame: From 0 to 96 hours after dosing
The occurrence rate of AE.
Time frame: From 0 to 96 hours after dosing
area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing.
Time frame: From 0 to 96 hours after dosing
area under the concentration-time curve from the time of dosing extrapolated to time infinity.
Time frame: From 0 to 96 hours after dosing
The PK parameters of the plasma sample.
Time frame: From 0 to 96 hours after dosing
The amount of time that a drug is present at the maximum concentration in serum.
Time frame: From 0 to 96 hours after dosing
The PK parameters of the plasma sample.
Yiling Pharmaceutical Inc.
Industry
A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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