A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remd… (NCT07510529) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Crossover Study to Evaluate the Relative Bioavailability of Two Formulations of Deuterated Remdesivir Hydrobromide for Oral Suspension in Healthy Chinese Adults
48 participantsStarted 2026-04-20
Plain-language summary
A single-center, open-label, randomized, two-sequence, two-period crossover study in 48 healthy subjects to compare the relative bioavailability of two formulations. The test (T, 0.2 g/sachet) and reference (R, 0.1 g/sachet) are administered at a dose of 0.2 g per period: sequence T-R receives 1 sachet T (period 1) and 2 sachets R (period 2); sequence R-T receives 2 sachets R (period 1) and 1 sachet T (period 2). Subjects are randomized 1:1 to either sequence.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Able to read, understand, voluntarily participate, and sign the informed consent form.
✓. Aged 18 to 50 years (inclusive) at screening, male or female.
✓. Body weight ≥50 kg for males and ≥45 kg for females, Body Mass Index (BMI) between 18 and 28 kg/m\^2\^ (inclusive) \[BMI = weight (kg) / height\^2\^ (m\^2\^)\].
✓. Vital signs, physical examination, laboratory tests, ECG, and chest X-ray (posteroanterior view) are normal or judged as abnormal without clinical significance by the investigator.
✓. Participants (including male participants) and their spouses/partners must have no pregnancy plan (including sperm/egg donation) from signing the informed consent form until at least 30 days after the last dose, and voluntarily agree to use effective contraceptive methods.
✓. Able to communicate well with clinical staff and complete the study per protocol requirements.
Exclusion criteria
✕. Presence of clinically significant diseases within 12 months before screening, including but not limited to digestive, circulatory, respiratory, endocrine, urinary, immune, nervous system disorders, and mental/psychological diseases.
✕. History of any condition with bleeding risk, such as acute gastritis or gastric/duodenal ulcer.
✕. Current history of oral ulcers, or acute or chronic infection within 1 week before screening.
✕. Major illness or major surgery within 3 months before screening, or anticipated major surgery during the study period.
What they're measuring
1
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Timeframe: From enrollment to Day10
2
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
Timeframe: From enrollment to Day10
3
Geometric mean ratios and their 90% confidence intervals for the primary PK parameters
✕. Blood donation or significant blood loss (\>400 mL) within 3 months before screening.
✕. Allergic constitution (allergic to multiple foods/drugs), or known allergy to the investigational product, its components, or related products.
✕. Positive test results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, HIV antigen/antibody, or Treponema pallidum antibody (TP-Ab).
✕. Positive pregnancy test at screening or baseline, or currently breastfeeding.