About this trial
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.
Eligibility criteria
Qualifiers
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/m²^ (inclusive) [BMI = weight (kg) / height²^ (m²^)].
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- T-R (Test-Reference drug)
- R-T (Reference-Test drug)