Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04214665
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2019-12-30
Brief Title:
To Assess the Bioequivalence of Test Oral Formulation of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Ilko Ilac San Ve Tic AS Versus Reference Thioctacid Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Meda Pharma GmbH CO KG Germany
Sponsor:
Ilko Ilac San ve Tic AS
Organization:
Ilko Ilac San ve Tic AS
Study Overview
Official Title:
A Randomized Open-label Balanced Two-treatment Four-period Two-sequence Single Dose Fully Replicate Crossover Oral Bioequivalence Study of Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Llko Ilac San Ve Tic AS Turkey and Thioctacid Alpha Lipoic Acid 600 mg HR Film Coated Tablets of Meda Pharma GmbH CO KG Germany in 28 Healthy Adult Human Subjects Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2020-01
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:
To assess the bioequivalence of test oral formulation of Alpha Lipoic acid 600 mg HR film coated tablets of Ilko Ilac San Ve Tic AS versus reference Thioctacid Alpha Lipoic acid 600 mg HR film coated tablets of Meda Pharma GmbH CO KG Germany
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