Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342778
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2024-03-11
Brief Title:
Pharmacokinetics and Bioequivalence of DoxylaminePyridoxine and Diclectin
Sponsor:
Valenta Pharm JSC
Organization:
Valenta Pharm JSC
Study Overview
Official Title:
Open-label Randomized Crossover Two-period Study of Comparative Pharmacokinetics and Bioequivalence of DoxylaminePyridoxine 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 After Meals in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine Pyridoxine enteric-soluble film-coated tablets 10 mg 10 mg Valenta Pharm JSC Russia and reference drug Diclectin delayed-release tablets 10 mg 10 mg registration certificate holder - Tzamal Bio-Pharma Israel manufacturer - Duchesnay Inc Canada in healthy volunteers after meals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None