A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

• Status: Not yet recruiting
• Trial end date: 2020-09-30
• Target enrollment: 0
• Participant gender: All

Summary

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.