Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06096571
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-10-13
Brief Title:
Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers
Sponsor:
Valenta Pharm JSC
Organization:
Valenta Pharm JSC
Study Overview
Official Title:
An Open-label Randomized Response-adaptive Crossover Study to Investigate the Comparative Pharmacokinetics and Bioequivalence of Aterixen 100 mg Tablets and Aterixen 100 mg Film-coated Tablets in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
1 Comparative evaluation of the safety of the drug Aterixen 100 mg tablets Valenta Pharm JSC Russia and Aterixen 100 mg film-coated tablets Valenta Pharm JSC Russia administered in single doses under fasting conditions in healthy volunteers based on AESAE adverse eventsserious adverse event analysis
2 Comparative assessment of pharmacokinetic parameters and bioavailability of Aterixen 100 mg tablets Valenta Pharm JSC Russia and Aterixen 100 mg film-coated tablets Valenta Pharm JSC Russia administered in single doses under fasting conditions in healthy volunteers
3 To conclude on the bioequivalence of Aterixen 100 mg tablets Valenta Pharm JSC Russia and Aterixen 100 mg film-coated tablets Valenta Pharm JSC Russia administered in single doses under fasting conditions in healthy volunteers
2 Comparative assessment of pharmacokinetic parameters and bioavailability of Aterixen 100 mg tablets Valenta Pharm JSC Russia and Aterixen 100 mg film-coated tablets Valenta Pharm JSC Russia administered in single doses under fasting conditions in healthy volunteers
3 To conclude on the bioequivalence of Aterixen 100 mg tablets Valenta Pharm JSC Russia and Aterixen 100 mg film-coated tablets Valenta Pharm JSC Russia administered in single doses under fasting conditions in healthy volunteers
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