Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 Tablet
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorReistone Biopharma Company Limited
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RSS0343 Tablet; Rifampicin Capsules
- RSS0343 Tablet; Clarithromycin Tablets
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov