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The pharmacokinetics of single and multiple doses of ASC16 quadruplex administration

The pharmacokinetics of single and multiple doses of ASC16 quadruplex administration

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040851
Enrollment
Unknown
Registered
2020-12-11
Start date
2019-05-07
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Basic Science

Interventions

A:ASC16 (200 mg, 1 tablet)
B:ASC08 (100 mg, 1tablet)
C:RTV (100 mg, 1tablet)
D:RBV (500 mg, 5tablet)
E:ASC16 (200 mg, 1 tablet) +ASC08/ R (100 mg/100 mg, 1 tablet /1 tablet) + RBV (500 mg, 5 tablets)
multiple dosing:Group F: ASC16 (200 mg, 1 tablet, QD) + ASC08/ R (100 mg/100 mg, 1 tablet /1 tablet, BID) + RBV (500 mg, 5 tablets, BID)

Sponsors

Nanning Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Between the ages of 18 to 45 years old, male or female; 2) The body weight of male subjects ranged from 50.0 to 75.0 kg, while that of female subjects ranged from 45.0 to 75.0 kg, and the body mass index (BMI) ranged from 19 to 26 kg/m2 (including boundary value). 3) Subjects voluntarily sign written informed consent.

Exclusion criteria

Exclusion criteria: 1) have a history or present history of any clinically serious disease, such as circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, metabolic abnormalities, or any other disease (e.g. anemia, hyperthyroidism, etc.) that may interfere with the test results; 2) (visit) screen for any infection-related signs or symptoms (such as fever, cough, respiratory infection or urinary tract infection, etc.) within 7 days before the screening; 3) Patients with allergies to drugs, food or other substances; 4) patients who have undergone surgery within 28 days before the study or plan to undergo surgery during the study; 5) have used any medicine or health care product (including Chinese herbal medicine) within 14 days before the test; 6) (visit) Use of any drug that inhibits or induces liver metabolism of drugs (e.g., inducers -- barbiturates, carbazepine, phenytoin, rifampicin) within 30 days before the test;Inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal drugs, HIV protease inhibitors, etc. 7) those who have used any clinical trial drug or enrolled in any clinical trial drug within 3 months prior to the trial; 8) (consultation) Blood donation or blood loss of more than 200 mL within 3 months before the test; 9) (visit) oral contraceptives used within 30 days before the trial, or long-acting estrogen or progesterone injections or implants used within 6 months before the trial; 10) (preliminary) 14 days before the test has been no protective agents (women), or during pregnancy or lactation women, or during the test can't take more than one kind of or non-drug contraception, or test over a period of 6 months for planner or pregnancy test over a period of 6 months can't take more than one kind of or contraception and have a sperm or egg donation program; 11) (consultation) those who have special requirements on diet and cannot follow the uniform diet; 12) (visit) Drinking excessive amount of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day for 3 months before the test; 13) (visit) have consumed or plan to consume any food or drink containing caffeine (e.g. coffee, strong tea, chocolate, etc.) or foods rich in xanthine (e.g. sardines, animal liver, etc.) or drinks within 48 hours before the first administration of the study drug; 14) (visit) those who have consumed or plan to consume grapefruit or grapefruitrelated citrus fruits (such as lime, grapefruit), dragon fruit, mango, star fruit, papaya, pomegranate or more fruits within 3 days before first taking the study drug; 15) (visit) smokers or those who had smoked more than 5 cigarettes per day in the 3 months before the study; 16) (visit) an alcoholic or a regular drinker in the 6 months prior to the trial, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of spirits of 40% alcohol or 150 mL of wine); 17) (visit) drug abusers or those who have used soft drugs (e.g., marijuana) within 3 months before the trial or hard drugs (e.g., cocaine, phenylhexidine, etc.) within 1 year before the trial; 18) (visit) defecation is irregular within 7 days before the test; 19) family history of cancer, history of tuberculosis or history of exposure to tuberculosis patients; 20) (consultation) patients who have difficulty in swallowing medicine or collecting blood, or are dizzy with acupuncture and blood; 21) Patients

Design outcomes

Primary

MeasureTime frame
PK parameter;

Countries

China

Contacts

Public ContactXuecheng Huang

Nanning Second People's Hospital

xchhnn@sina.com+86 771-4808493

Outcome results

None listed

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