Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441916
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-26
Brief Title:
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
Sponsor:
International Bio service
Organization:
International Bio service
Study Overview
Official Title:
A Single Dose Randomized Open-label Two-treatment Four-period Two-sequence Replicate Crossover Bioequivalence Study of Generic Dabigatran Etexilate Capsules 150 mg and Reference Product Pradaxa in Healthy Thai Volunteers Under Fasting Conditions and Under Pre-treatment With a Proton Pump Inhibitor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheims Pradaxa will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of free dabigatran and total dabigatran
Detailed Description:
Bioequivalence study is a research study that needs to compare the rate and extent to which the active substance or active moiety is absorbed from a pharmaceutical dosage form between innovator or reference product and test product when given in healthy subjects at the same dose and strength The acceptance criteria in bioequivalence study will be done by comparing the pharmacokinetic parameters including maximal plasma concentration Cmax time at which the maximum plasma concentration occurs Tmax and area under the plasma concentration curve AUC either area under the plasma concentration curve from administration to last observed concentration at time t AUC0-tlast or area under the plasma concentration curve extrapolated to infinite time AUC0- Those parameters should be calculated only from the plasma concentration and time curve but cannot use other data obtained from in vitro study By this reason it is necessary to conduct the study in healthy subjects
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