Shanghai Xuhui Central Hospital
Shanghai, China
NCT Number: NCT04623814
Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC113995 PA•H2O in Healthy Subjects
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HEC113995 20mg will be taken orally fasted or with food
HEC113995 will be taken orally fasted (HEC113995 10mg)or with food (HEC113995 20mg and 40mg) for 10 days
The placebo will be administered fasted or with food for 10 days.
Time frame: up to 34 days
To assess the safety and tolerability of therapy
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Time frame: up to 120 hours
Sunshine Lake Pharma Co., Ltd.
Industry
HEC113995-A Phase I,Double-Blind, Placebo-Controlled, Multiple Oral Dose, Safety, Tolerability, Pharmacokinetics and Food Effect Study in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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