Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT05498233
Brief 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).
Study:
NCT05498233
Study Brief:
Protocol Section:
NCT05498233