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A Drug-drug Interaction(DDI) Study Of Yimitasvir And Rosuvastatin In Healthy Male Subjects

A Open-label, Single Center Drug-drug Interaction Study of Yimitasvir Phosphate Capsule And Rosuvastatin Calcium Tablets In Healthy Male Subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021628
Enrollment
Unknown
Registered
2019-03-02
Start date
2019-03-05
Completion date
Unknown
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis C

Interventions

Case series:Yimitasvir100mg+Rosuvastatin10mg

Sponsors

the First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Subjects must be sign a written informed consent form voluntarily and fully understand the study content, process and possible adverse reactions; 2) Subjects is able to complete the study in compliance with the protocol; 3) Subjects (including partners) are willing to voluntarily take effective contraceptive measures from screening until to the last study drug administration; 4) Healthy male subjects between 18 and 45 years of age, inclusive; 5) Body weight should be=50 kg; Body Mass Index (BMI) is between 19 and 25 kg/m2, inclusive; 6) Physical examination and vital signs without clinically significant abnormalities.

Exclusion criteria

Exclusion criteria: 1) Smokers, who smoke more than 5 cigarettes/day within 3 months before the study; 2) Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine); 3) Donated blood or massive blood loss within 3 months before screening (>450 mL); 4) Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers; 5) Have take any drug that changes liver enzyme activity within 1 month before taking the study drug; 6) Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening; 7) Have participated in any clinical trial or taken any study drug within 3 months before dosing; 8) Viral hepatitis(including CHB and CHC)and positive test result of anti-HIV Ab or syphilis; 9) Have taken any alcoholic products within 24 hours prior to taking the study drug.

Design outcomes

Primary

MeasureTime frame
safety;pharmacokinetics;

Countries

China

Contacts

Public ContactRowling luo

Sunshine lake pharma co.Ltd

luolin@hec.cn+86 769 8531 5888-2535

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026