About this trial
The objective of this study is to investigate the efficacy, safety, and tolerability of investigational product Ingavirin forte capsules (Valenta Pharm JSC) administered at different doses compared with medicinal product Ingavirin, 90 mg, capsules (Valenta Pharm JSC) in subjects with influenza or other acute respiratory viral infections (ARVIs).
Eligibility criteria
Qualifiers
Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;
Males and females aged 18 to 65 years (inclusive) at the time of signing the ICF;
Subjects with influenza or other acute respiratory viral infections confirmed by polymerase chain reaction (PCR);
Body temperature >38,0 °С at randomization, with no intake NSAID within 12 hours before randomization;
Disqualifiers
Clinically significant allergic history;
Hypersensitivity to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;
Intolerance to active substances of medical produtcs Ingavirin and Ingavirin forte, and/or to any excipient contaned in the investigational medicinal product or comparator;
Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;
Trial design
Treatments tested in this trial
- Ingavirin Forte, 90 mg + 5 mg, Capsules
- Ingavirin Forte, 90 mg + 10 mg, Capsules
- Ingavirin Forte, 90 mg + 20 mg, Capsules
- Ingavirin, 90 mg, Capsules
- Placebo