- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07696091
Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 Tablet
6 juli 2026 uppdaterad av: Reistone Biopharma Company Limited
A Single-center, Single-sequence, Self-controlled Open Design Study , to Investigate the Effects of Rifampicin and Clarithromycin on the Pharmacokinetics of RSS0343.
This study is a single-center, single-sequence, self-controlled, open design, aiming to investigate the effects of rifampicin and clarithromycin on the pharmacokinetics of RSS0343 in humans.
Studieöversikt
Status
Har inte rekryterat ännu
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
40
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ruifang Guan
- Telefonnummer: +86- 0518-82342973
- E-post: ruifang.guan.rg1@hengrui.com
Studera Kontakt Backup
- Namn: Hongda Lin
- Telefonnummer: +86- 0518-82342973
- E-post: hongda.lin@hengrui.com
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510405
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
-
Huvudutredare:
- Dawei Wang
-
Huvudutredare:
- Yan Ling
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- The participants voluntarily signed the informed consent form, fully understanding the purpose and significance of this trial and willing to abide by the trial protocol.
- Age range: 18 - 55 years old (inclusive of both boundaries), open to both genders.
- Male weight ≥ 50 kg, female weight ≥ 45 kg. Body mass index (BMI) = weight (kg) / height² (m²). BMI is within the range of 19 to 28 kg/m² (including the boundary values).
- Male and female participants with reproductive capacity, as well as their partners, should have no plans for conception or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last administration of the drug, and should voluntarily adopt effective contraceptive measures. For female participants with reproductive capacity, the serum pregnancy test must be negative before the first administration of the drug, and they should not be in the lactation period.
Exclusion Criteria:
- Those who smoked more than 5 cigarettes per day in the previous 3 months (or used any nicotine-containing products), or those who planned to use any tobacco products during the trial period.
- Select individuals who have consumed alcohol frequently within the past 6 months (for women, the daily alcohol intake exceeds 15 g, and for men, it exceeds 25 g [5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, or approximately 17 mL of low-alcohol liquor]; and who cannot stop using any alcoholic products during the trial period); or those whose alcohol breath test was positive at baseline.
- Those with a history of drug abuse, drug use, drug dependence (during the consultation), or positive results from the baseline urine drug screening.
- Within one month before administration, having donated blood or experiencing blood loss of a total volume of ≥ 200 mL, or having donated blood or experienced blood loss of a total volume of ≥ 400 mL within the previous three months; or having received blood transfusion within the previous eight weeks; or having difficulty in venous blood collection, or being physically unable to withstand intensive blood collection.
- The researchers believe that participants who have other factors that make them unsuitable to participate in this trial.
- The results of physical examination, vital signs, laboratory tests (such as blood routine, urine routine, liver and kidney function, blood biochemistry, coagulation function, thyroid function, etc.), chest imaging, abdominal B-ultrasound and 12-lead electrocardiogram examination, when judged abnormal by the researchers, have clinical significance.
- Those who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
- Suspected of being allergic to the studied drug or any component of the drug, or having a severe allergy to any medication, food, toxin or other exposure.
- Any history of severe clinical diseases or conditions that the researcher believes may affect the trial results, including but not limited to diseases of the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases; or conditions that the researcher believes may affect the research results or affect the absorption, distribution, metabolism and excretion of the drug or expose the participants to inappropriate risks.
- Exclude those who have undergone any surgery within the past 3 months, or those who have not fully recovered as determined by the researchers, or those who plan to undergo any surgery during the study period or within 1 month after the study concludes.
- Within the first 1 month before the baseline, or within 5 half-lives of the medication (whichever is longer), or during the study period, the use of other CYP3A inducers and inhibitors, any prescription drugs, over-the-counter drugs, including natural health supplements (with the exception of occasional use of paracetamol [up to 2g per day], ibuprofen, or regular use of vitamins) or Chinese herbal medicines.
- From 48 hours before the baseline until the end of the study, participants were required to refrain from consuming any beverages or foods containing methylxanthines, such as coffee, tea, cola, chocolate, etc.; from 7 days before the baseline until the end of the study, participants were required to refrain from consuming any beverages or foods containing grapefruit; those with special dietary requirements and unable to follow the unified diet.
- Those who received any live vaccine or attenuated live vaccine within the previous 1 month, or those who need to receive a live vaccine during the study period (including 30 days after the last administration of the study drug).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cohort A: Rifampicin Capsules Group
|
RSS0343 Tablet; Rifampicin Capsules
|
|
Experimentell: Cohort B: Clarithromycin Tablets Group
|
RSS0343 Tablet; Clarithromycin Tablets
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cmax; The maximum plasma concentration
Tidsram: Day1-Day38
|
Day1-Day38
|
|
AUC0-t; From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration
Tidsram: Day1-Day38
|
Day1-Day38
|
|
AUC0-inf;Area under the concentration curve from time 0 to extrapolated infinite time
Tidsram: Day1-Day38
|
Day1-Day38
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Tmax; Time to maximum plasma concentration
Tidsram: Day1-Day38
|
Day1-Day38
|
|
t1/2; Terminal half-life
Tidsram: Day1-Day38
|
Day1-Day38
|
|
CL/F; Apparent clearance
Tidsram: Day1-Day38
|
Day1-Day38
|
|
Vz/F; Apparent volume of distribution
Tidsram: Day1-Day38
|
Day1-Day38
|
|
Safety ;Incidence and severity of adverse events
Tidsram: Day1-Day45
|
Day1-Day45
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
1 september 2026
Studieregistreringsdatum
Först inskickad
6 juli 2026
Först inskickad som uppfyllde QC-kriterierna
6 juli 2026
Första postat (Faktisk)
10 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RSS0343-103
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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