An open-label bioavailability and safety study on the single dosepharmacokinetics of the antiviral compound ZingiVir-H after oral administrationin healthy males.

Pankajakasthuri herbal research foundation0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Willing and able to provide written informed consent prior to performing study
•procedures by the subject or legal guardian.
•Willing to stay in-house as per protocol for 48 hours from Day 0, Hour-01.
•Radiographic evidence of NO pulmonary infiltrates
•Normal ECG pattern
•Healthy volunteers, aged between 18 and 45 years;
•Body mass index (BMI) between 20 to 26 kg per m2;
•Normal findings in the physical examination and vital signs:
•Blood pressure (BP) Systolic Between 115-135 and Diastolic Between 75-90 mmHg
•AND Heart rate (HR) between 60-80 beats per minute, both measured after three minutes
•Body temperature between 35.8 C and 37.5 C;
•Normal laboratory values in CBC, LFT and RFT Clinically not significant as per
•Investigator discretion

•If the Volunteers experiences any acute illness in the 2 weeks before study screening day
•0 (study visit 1).
•Any active concomitant cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal,
•neurological, hematological, hepatic or renal diseases, unless deemed not clinically
•significant as per the investigator discretion.
•Donated blood or had significant loss of blood within 2 months (or donated plasma
•within 7 days) of study day 0,
•Had a positive test for or received treatment for hepatitis B, hepatitis C, HIV and/or other
•immunodeficiency disorders,
•History of receiving any medication that might have had carry-over effects into this
•Use of any prescription medication in the 14 days preceding this study;
•Use of over-the-counter (OTC), homeopathic or herbal medicines in the 14 days
•preceding this study.
•Use of Zingivir-H medicine in the 45 days preceding the study.

发起方

Pankajakasthuri herbal research foundation