Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178640
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-12-08
Brief Title:
Bioequivalence Study of Simvastatin 40 mg Film-coated Tablets in Healthy Thai Volunteers
Sponsor:
International Bio service
Organization:
International Bio service
Study Overview
Official Title:
A Single Dose Randomized Open-label Replicated Crossover Bioequivalence Study of Generic Simvastatin 40 mg Film-coated Tablets and Reference Product ZOCOR in Healthy Thai Volunteers Under Fasting Conditions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
The goal of this bioequivalence study is to determine and compare the rate and extent of absorption and to evaluate safety of test and reference formulations Study Design An open label randomized two-treatment four-period two-sequence replicate crossover bioequivalence study in 46 healthy Thai volunteers under fasting conditions with at least 7 days washout period
Detailed Description:
The primary objective of this bioequivalence study is to assess and compare the rate and extent of absorption of a test formulation against a reference formulation with an additional focus on evaluating the safety profiles of both formulations This study aims to provide critical insights into the bioequivalence of the two formulations shedding light on their pharmacokinetic parameters and overall safety in the context of therapeutic efficacy
Study Design
The study adopts an open-label randomized two-treatment four-period two-sequence replicate crossover design to ensure robustness and reliability in the evaluation of bioequivalence The crossover design minimizes the impact of inter-individual variability allowing for a more accurate assessment of the formulations performance
Participant Selection
A total of 46 healthy Thai volunteers will be recruited to participate in the study The inclusion criteria involve individuals who meet specific health standards and are willing to comply with the study requirements The emphasis on recruiting healthy volunteers aims to establish a baseline for comparison ensuring that any observed differences in absorption and safety can be attributed to the formulations under investigation
Study Conditions
The study will be conducted under fasting conditions to isolate the impact of the formulations on absorption without interference from food-related variables Fasting conditions provide a controlled environment to evaluate the formulations performance and allow for a more accurate determination of bioequivalence
Study Design
The study adopts an open-label randomized two-treatment four-period two-sequence replicate crossover design to ensure robustness and reliability in the evaluation of bioequivalence The crossover design minimizes the impact of inter-individual variability allowing for a more accurate assessment of the formulations performance
Participant Selection
A total of 46 healthy Thai volunteers will be recruited to participate in the study The inclusion criteria involve individuals who meet specific health standards and are willing to comply with the study requirements The emphasis on recruiting healthy volunteers aims to establish a baseline for comparison ensuring that any observed differences in absorption and safety can be attributed to the formulations under investigation
Study Conditions
The study will be conducted under fasting conditions to isolate the impact of the formulations on absorption without interference from food-related variables Fasting conditions provide a controlled environment to evaluate the formulations performance and allow for a more accurate determination of bioequivalence
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