NCT05498233

Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers

Open Randomized Cross-over Two-period Study on Comparative Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Enteric-soluble Film-coated Tablets, 10 mg + 10 mg (Valenta Farm, Russia) in Healthy Volunteers in Fasted Conditions

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

Summary

The study aimed for: 1. Comparative assessment of pharmacokinetic parameters and bioequivalence of the drug Doxylamine + Pyridoxine, enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and Diclectin, delayed-release tablets, 10 mg + 10 mg (registrant: Tzamal Bio-Pharma, Israel, manufacturer: Duchesnay Inc, Canada), in healthy volunteers in fasted conditions. 2. Comparative evaluation of the safety of the drug Doxylamine + Pyridoxine, enteric-soluble film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSK, Russia), and Diclectin, delayed-release tablets, 10 mg + 10 mg (registrant: Tzamal Bio-Pharma, Israel, manufacturer: Duchesnay Inc, Canada), based on the analysis of adverse events (AEs).

Conditions

• Pregnancy Related
• Nausea

Interventions

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

Timeline

• Start date: 2022-08-18
• Primary completion: 2022-09-19
• Completion: 2022-09-19
• First posted: 2022-08-12
• Last updated: 2023-07-27

Locations

1 site across 1 country: Russia