None listed
Conditions
Interventions
Intervention1: ZingiVir H: Dose : single dose of 500 mg tab
Frequency: only once .
As it is Bioavailability study a single dose of 500 mg ZingiVir H is administered in healthy volunteers orally.The
Sponsors
Pankajakasthuri herbal research foundation
Eligibility
Inclusion criteria
Inclusion criteria: 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 sitting. 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
Exclusion criteria
Exclusion criteria: 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 study. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this single-dose study is to assess the bioavailability and ADME mechanism on single-dose administration of Zingivir-H as 500 mg dosage in tablet form in healthy male adults.Timepoint: 0, 1 and 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the tolerability and safety profiles of the single dosage of Zingivir-H as 500 mg in this test population. Timepoint: 0,2 nd day | — |
Countries
India
Contacts
Public ContactDr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation
Outcome results
None listed