NCT06342778

Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin Under Fed Conditions in Healthy Volunteers

An Open-label, Randomized, Crossover, Two-period Study of the Comparative Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine, 10 mg + 10 mg Enteric-soluble Film-coated Tablets (Valenta Pharm JSC, Russia) and Diclectin, 10 mg + 10 mg Delayed-release Tablets (Duchesnay Inc, Canada) Under Fed Conditions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nausea

Interventions

Type	Name	Description
DRUG	Doxylamine + Pyridoxine	A single dose of R or T drug in each of 2 periods of the study under fed conditions
DRUG	Diclectin	A single dose of R or T drug in each of 2 periods of the study under fed conditions

Timeline

• Start date: 2024-02-27
• Primary completion: 2024-05-02
• Completion: 2024-05-02
• First posted: 2024-04-02
• Last updated: 2025-07-11

Locations

1 site across 1 country: Russia