Healthy Volunteer Clinical Trial
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
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's 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.
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06326723 -
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT00001367 -
Diagnosis and History Study of Patients With Different Neurological Conditions
|
||
| Completed |
NCT02699710 -
Effect of Food, Rabeprazole, Methotrexate and Formulation on the Pharmacokinetics (PK) of GDC-0853 and the Effect of GDC-0853 on the PK of Methotrexate in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02231892 -
Repetitive Transcranial Magnetic Stimulation Equipment Testing and Pilot Study
|
N/A | |
| Completed |
NCT03771586 -
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT06337422 -
Bioequivalence Study of Generic Celecoxib 200 mg Capsules
|
Phase 1 | |
| Completed |
NCT03302182 -
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT05049343 -
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
|
Phase 1 | |
| Recruiting |
NCT01629108 -
Normal Values in Hearing and Balance Testing
|
||
| Completed |
NCT02947854 -
Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant
|
Phase 1 | |
| Completed |
NCT02534870 -
Pharmacokinetics and Safety of the Co-administration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT02224053 -
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01684891 -
A 28-Day Pharmacokinetics Study of RG1662 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01711762 -
A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT01697436 -
A Bioequivalence Study of an Oral Solution of Copegus (Ribavirin) Compared to Copegus Tablets
|
Phase 1 | |
| Completed |
NCT01676584 -
A Study of Single Dose RO6811135 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01591850 -
A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01433575 -
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
|
Phase 1 | |
| Completed |
NCT01579149 -
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
|
Phase 1 | |
| Completed |
NCT01414881 -
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
|
Phase 1 |