Clinical trials: sponsored by Sunshine Lake Pharma Co., Ltd.
Influenza
Single Dose and Multiple Dose Safety, Tolerability, PK，and Food Effect Study，and Interaction With Oseltamivir Study of HEC116094 in Healthy Adult Subjects
The Safety, Tolerability, Pharmacokinetic, Food Effect Study and the interaction with Oseltamivir Phosphate Capsules of HEC116094 in Healthy Subjects
- Trial name
- NCT04982913
- Testing
- HEC116094
- Where
- China
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatitis B, Chronic
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B
- Trial name
- NCT05391360
- Testing
- Freethiadine tablets(part I), Freethiadine tablets (part II), entecavir tablets
- Where
- 2 sites in China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Diabetic Nephropathy
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC73077 in Healthy Subjects
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC73077 in Healthy Subjects
- Trial name
- NCT05492630
- Testing
- HEC73077 tablets
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Adult Male Volunteers
ADME Study of [14C]- Rongliflozin in Healthy Male Subjects
Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]- Rongliflozin in healthy male subjects.
- Trial name
- NCT05109078
- Testing
- [14C]- Rongliflozin
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Esophageal Squamous Cell Carcinoma
Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification
The purpose of this study is to evaluate the safety and efficacy of Z650 in Advanced Esophageal Squamous Cell Carcinoma patients With EGFR Over expression or Gene Amplification.
- Trial name
- NCT03888092
- Testing
- Z650
- Where
- China
- Volunteers
- 81 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Acute Myeloid Leukemia in Children
Clifutinib Food Effect Study in Healthy Subjects
The purpose of this study is to evaluate to determine the effect of food on the PK of a single dose of 40 mg Clifutinib in healthy subjects.
- Trial name
- NCT05454098
- Testing
- Clifutinib with fed state, Clifutinib with fasted state
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Adult Male Volunteers
ADME Study of [14C]- Larotinib in Healthy Male Subjects
Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]-Larotinib（Z650）in healthy male subjects.
- Trial name
- NCT05059743
- Testing
- [14C]-Larotinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Type 2 Diabetes Mellitus
Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects
This is a phase I, open-label, fixed-sequence study in healthy Chinese subjects, performed at a single study centre. Cohort A will assess the Pharmacokinetic (PK) profile of rongliflozin when administered alone and the…
- Trial name
- NCT05497674
- Testing
- Rongliflozin, Rifampin, Probenecid
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Male Subjects
ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Antaitavir Hasophate.
- Trial name
- NCT05446233
- Testing
- [14C] Antaitavir Hasophate
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Subjects
Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114
This is a single center, open-label study to investigate whether HEC74647 and HEC110114 has an effect on the pharmacokinetic (PK) profile of midazolam（a cytochrome (CYP) 3A4 substrate）in healthy subjects
- Trial name
- NCT05504876
- Testing
- Midazolam Syrup, HEC74647PA, HEC110114
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Renal Impairment
Pharmacokinetics of Yimitasvir Phosphate Capsule in Subjects With Normal Renal Function and ESRD
This study is to evaluate the single-dose pharmacokinetics (PK) and safety of Yimitasvir phosphate capsule in participants with End-stage renal disease without hemodialysis using matched healthy participants as a control group.
- Trial name
- NCT04565171
- Testing
- Yimitasvir Phosphate Capsule
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatic Impairment
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects
To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT04552808
- Testing
- Yimitasvir Phosphate
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Type 2 Diabetes
A Clinical Study Comparing the Pharmacokinetics and Pharmacodynamic Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection (Tresiba®) in Healthy Subjects
To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®) listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided by Dongguan Dongyang Sunshine…
- Trial name
- NCT05576298
- Testing
- Insulin degludec injection, RD15003, Insulin degludec, Tresiba
- Where
- China
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Type 2 Diabetes
A Pharmacokinetic Study Comparing the 14028 Injection and TRULICITY® in Healthy Chinese Subjects
To evaluate the pharmacokinetics similarity between the 14028 injection produced by Sunshine Lake Pharma Co., Ltd. and dulaglutide injection (TRULICITY®) produced by Eli Lilly and Company for single dose in healthy male subjects…
- Trial name
- NCT05459285
- Testing
- 14028 injection, dulaglutide injection
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Advanced Refractory Solid Tumors
Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors
Clinical study of HEC68498 in patients with advanced refractory solid tumors. The primary objective is to determine the maximum tolerated dose and dose limiting toxicity of HEC68498 in patients with advanced refractory solid…
- Trial name
- NCT04324372
- Testing
- HEC68498
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Chronic Hepatitis B
GLS4/RTV and TAF Drug-drug Interaction
The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
- Trial name
- NCT04551261
- Testing
- GLS4, RTV, TAF
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Idiopathic Pulmonary Fibrosis
To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers
An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or Nintedanib in healthy volunteers
- Trial name
- NCT05383131
- Testing
- HEC585, Pirfenidone, Nintedanib
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Pancreatic Cancer
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.
- Trial name
- NCT04131192
- Testing
- Z650, Gemcitabine
- Where
- 2 sites in China
- Volunteers
- 13 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Type 2 Diabetes
A Pharmacokinetic Study Comparing the Liraglutide Injection (RD12014) and Victoza® in Healthy Chinese Subjects
To evaluate the pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd.
- Trial name
- NCT05294536
- Testing
- Liraglutide injection,RD12014, Liraglutide injection,Victoza
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Idiopathic Pulmonary Fibrosis
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects
The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects
- Trial name
- NCT04512170
- Testing
- HEC585
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.