Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin Under Fed Conditions in Healthy Volunteers
Status:
COMPLETED
Trial end date:
2024-05-02
Target enrollment:
Participant gender:
Summary
This study aims to evaluate pharmacokinetic profile and establish bioequivalence of the investigational drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia) compared to the reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers under fed conditions.
Phase:
PHASE1
Details
Lead Sponsor:
Valenta Pharm JSC
Treatments:
dicyclomine, doxylamine, pyridoxine drug combination Doxylamine Pyridoxine