A Study to Evaluate the Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
NCT ID: NCT03430830
Last Updated: 2018-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2018-01-15
2018-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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GROUP 1
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 19th to 25th day： Ravidasvir 200mg administered orally once daily.
Ravidasvir 50mg
50mg, Tablet
Ravidasvir 200mg
200mg, Tablet
GROUP 2
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily ; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Ravidasvir 50mg
50mg, Tablet
Ravidasvir 200mg
200mg, Tablet
GROUP 3
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Ravidasvir 50mg
50mg, Tablet
Ravidasvir 200mg
200mg, Tablet
GROUP 4
1st day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: Ravidasvir 200mg administered orally once daily; 3rd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Ravidasvir 50mg
50mg, Tablet
Ravidasvir 200mg
200mg, Tablet
GROUP 5
1st day: Ravidasvir 200mg administered orally once daily; 2nd day: 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Ravidasvir 50mg
50mg, Tablet
Ravidasvir 200mg
200mg, Tablet
GROUP 6
1st day: 2 tablets of Ravidasvir 50mg administered orally once daily; 2nd day: 1 tablet of Ravidasvir 200mg and 2 tablets of Ravidasvir 50mg administered orally once daily; 3rd day: Ravidasvir 200mg administered orally once daily; 19th to 25th day：Ravidasvir 200mg administered orally once daily.
Ravidasvir 50mg
50mg, Tablet
Ravidasvir 200mg
200mg, Tablet
Interventions
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Ravidasvir 50mg
50mg, Tablet
Ravidasvir 200mg
200mg, Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male body weight not less than 50kg; Female body weight not less than 45kg; BMI in the range of 19\~24kg/m2
* Healthy men or women based on history, physical examination, laboratory examination and ECG.
* no plan of pregnancy in at least six months, and willing to take effective measures to prevent contraception from the first time when the drug is administered till the last time the drug is administered within 30 days.
* Female has negative pregnancy tests at the screening stage.
* Voluntary to sign the informed consent.
Exclusion Criteria
* Has a history of drug or food allergy.
* Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening.
* Laboratory tests out of normal range and judged by the investigators as clinically significant.
* Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery.
* Pregnant, lactating women and people who unwilling to take effective measures to prevent contraception.
* People who consumed pomelo, apple or orange and foods or drinks containing their extracted ingredients within 3 days of taking the drug.
* Any prescription or over-the-counter medications, herbs, and vitamins are required to be taken prior to or within the first month of taking the drug.
* Selected within the first 6 months of smoking, alcohol, drug abuse or history of drug abuse.
* Selected within the first 3 months had blood loss or blood donation of 200ml.
* Participate in other clinical trials within the first 3 months of the study and received other study drug treatment.
* In addition to the above, the investigators judged not suitable for participating in this clinical trial.
18 Years
45 Years
ALL
Yes
Sponsors
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Ascletis Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yahong Chen, Master
Role: STUDY_DIRECTOR
Ascletis Pharmaceuticals Co., Ltd.
Locations
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First Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Countries
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References
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Wu G, Zhou H, Wu J, Lv D, Wu L, Zhai Y, Lin M, Wu JJ, Shentu J. Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects. Antimicrob Agents Chemother. 2021 Sep 17;65(10):e0060021. doi: 10.1128/AAC.00600-21. Epub 2021 Jul 12.
Other Identifiers
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ASC-ASC16-I-CTP-03
Identifier Type: -
Identifier Source: org_study_id