An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.

You likely can't join if

• 1. Use of any prescription or OTC medication within 28 days before the first dosing is scheduled (including vitamins, food supplements and herbal supplements), except for oral contraceptives and hormonal replacement therapy, taken without significant changes in dose for 90 days prior to the first dosing. 2. Use of organ-toxic drugs or systemic drugs known to substantially alter liver metabolism, especially including medication containing CYP1A2 inducers and/or inhibitors within 90 days before the first dosing. 3. Participation in any other clinical study or receive treatment with any investigational drug or device within 30 days or at least 5 half-lives, whichever is longer, prior to screening. 4. Serious mental disease and/or inability to cooperate with clinical team. 5. Hematological, gastrointestinal, cardiovascular, renal (with impaired renal function), or hepatic diseases and/or pathological findings present or in history, which might interfere with the drug pharmacokinetics. 6. Current or history of diabetes mellitus, thyroid disease, neurologic disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. 7. Acute or chronic disease and/or clinical findings which may interfere with the aims of the study or with the drug’s safety, tolerability, bioavailability and/or pharmacokinetics of the IMP. 8. Current or history of cardiac arrhythmias or other cardiac disease, hematologic (blood) disease, coagulation disorders, lipid abnormalities, and respiratory disease, that the Investigator considers should excluded the participant from the study. 9. Severe hepatic impairment, level of serum transaminases ALT or AST ≥2.0 x ULN at the screening. 10. Clinically significant illness within 28 days before the first dosing, including major surgery. 11. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator. 12. Subjects who are found positive to HIV, HBsAg and HCV serological tests at screening visit. 13. Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening (or at admission to the study center) as deemed appropriate by the investigator. Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the Investigator. 14. Body temperature is consistently out of the range of 35.4 - 37.0°C (< 35.4 and ≥ 37.0 °C) at screening and at check-in. 15. Getting a tattoo, body piercing or any cosmetic treatment involving skin penetration within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study. 16. Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing. 17. Anaemia, haemoglobin below 120 g/L for women and 130 g/L for men at screening. 18. State of veins on upper extremities does not allow or complicates blood collection. 19. Use of any recreational drugs or history of drug abuse or alcoholism. 20. Use of antiviral medication (including locally administered) within 14 days or 10 half lives, whichever is longer, before the first dose of the study drug is scheduled. 21. Current diagnosis of renal impairment, with creatinine clearance < 50 mL/min/1.73 m2 at the screening. 22. History of severe allergy or allergic reactions to acyclovir, valacyclovir, or its analogues, or heparin or to any of the excipients. 23.– 25. COVID-19 ex.cr. (see protocol). 26. Any other condition or abnormal findings that, in the investigator’s judgement, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.