Pharmacokinetics of arbidol hydrochloride suspension in healthy Chinese volunteers

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2012
INTERVENTION: A‐Single‐Dose Phase:This was a single‐dose, open‐label, randomized, 3‐sequence, crossover study. In accordance with the randomization scheme, subjects were assigned to receive a single 0.2, 0.4 and 0.8 g dose of arbidol hydrochloride suspension with a 7‐day washout period between administration. The 3‐sequence consisted of equal numbers of men and women.;B‐Multiple‐Dose Phase:Followed single‐dose phase , volunteers assigned to continued into the multiple‐dose phase, during which they were received the 0.2 g dose three times daily for 7 consecutive days.; CONDITION: viral infection PRIMARY OUTCOME: AUC(0‐8);AUC(0‐t);Cma;AUC(0‐infinite); INCLUSION CRITERIA: 1. Healthy subjects of both sexes were eligible; 18 to 35 years of age, BMI 19 to 24 kg/m2; 2. All participants were in good health according to medical history, physical examination, 12‐lead ECG, blood pressure and pulse rate and clinical laboratory measurements (i.e., hematology, blood biochemistry, hepatic function, a positive test for hepatitis B virus, and urinalysis); 3. Subjects were excluded if they were smokers, tobacco users or taking any medication (including over the counter medication) within 14 days prior to dosing, or caffeine‐containing beverages were consumed within 72 h predose; 4. Each subject was informed about the nature and risk associated with the study, and has signed an informed consent form before participating.
Epistemonikos ID: 1202233ad04d21d4a4d18556c7224c1129db0327
First added on: Aug 22, 2024