Status:
UNKNOWN
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.
Lead Sponsor:
Xi'an Xintong Pharmaceutical Research Co.,Ltd.
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers
Detailed Description
It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir F...
Eligibility Criteria
Inclusion
- Able to understand the nature of the study, comply with the protocol, and provide informed consent.
- Subjects willing to adhere to protocol requirements and to finish the study.
- Subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration.
- Subjects aged between 18 and 55 years (both inclusive).
- Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale.
- Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
Exclusion
- History or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug).
- Hypersensitivity to different kinds of drugs and food.
- Presence of significant alcoholism or drug abuse.
- Volunteer who have donated blood or lose blood(\>450mL)within past 90 days prior to the first dose of the study drug.
- Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study.
- Use of any prescribed medication or OTC medicinal products during the last 14 days prior to dosing of the study.
- Consumption of spcial food(including gragon fruit, mango, grapefruits) or strenuous excercise,or other factors which may effect the absorption,distribution,metabolism,excretion of drugs for within 2 weeks prior to dosing of the study.
- Any treatment which could bring about induction or inhibition of CYP3A4.
- Volunteer who have participation in a drug research study within past 90 days prior to the first dose of the study drug.
- Difficulty in swallowing or other gastrointestinal disease or disorder.
- Presence of an abnormal electrocardiogram (ECG), which was clinically significant.
- Female subjects who were breast-feeding or had a positive pregnancy test at screening or at any time during the study.
- Subjects with abnormal health as determined by personal medical history, clinical examination and laboratory examinations,which was clinically significant.
- Subjects who, in the opinion of the Investigator, should not participate in the study.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04277897
Start Date
March 15 2020
End Date
September 30 2020
Last Update
February 20 2020
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