Clinical trials: Apixaban
Anticoagulation
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects
The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.
- Trial name
- NCT02074358
- Testing
- Apixaban, Cofact (4-Factor PCC), Beriplex P/N (4-Factor PCC)
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Random Allocation, Intermittent Fasting
Pivotal BE Study of TAH3311 ODF vs ELIQUIS® Tablet Under Fasted Condition in Healthy Volunteers
This single-dose, open-label, randomized, four-way crossover study evaluates the pharmacokinetics, safety, and tolerability of TAH3311 5 mg in healthy volunteers under fasted and fed conditions.
- Conditions
- Random Allocation, Intermittent Fasting, Enteral Feeding
- Trial name
- NCT06689436
- Testing
- 5 mg Apixaban Oral Dissolving Film (fasting), 5 mg Apixaban Oral Dissolving Film (fed), 5 mg Apixaban Oral Tablet (US RS/RLD)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- TAHO Pharmaceuticals Ltd.
Venous Thromboembolism, Pharmacokinetics
Drug Interaction Study of Apixaban With Cyclosporine and Tacrolimus
This study aims to evaluate the pharmacokinetics (PK) of apixaban when co-administered with cyclosporine and tacrolimus in healthy volunteers.
- Conditions
- Venous Thromboembolism, Pharmacokinetics, Healthy
- Trial name
- ACT (NCT03083782)
- Testing
- Apixaban alone, Cyclosporine, Tacrolimus
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Thomas Jefferson University
Antithrombic Drug
Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under…
- Trial name
- NCT06043297
- Testing
- Apixaban 5MG, Eliquis 5 mg
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Thrombosis
Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers
To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet
- Trial name
- NCT00914641
- Testing
- Apixaban IR, Apixaban MR1, Apixaban MR2
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bleeding
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.
- Trial name
- NCT02207725
- Testing
- Andexanet
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Health
Bioequivalence Study of Apixaban 5 mg Film-Coated Tablet
This was an open-label, randomized, single-dose, two-period, two-sequence, cross-over study under fasting condition which included 24 healthy adult male and female subjects.
- Trial name
- NCT06817811
- Testing
- Apixaban 5 mg Film-Coated Tablet (produced by PT Dexa Medica), Eliquis® 5 mg film-coated tablet (Bristol-Myers Squibb Company, Puerto Rico, packed and released by Bristol-Myers Squibb S.r.l., Italy, imported by PT Pfizer Indonesia)
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Nephrotic Syndrome, Proteinuria
Pharmacokinetics of Apixaban in Nephrotic Syndrome
This study is to investigate the pharmacokinetics and pharmacodynamics of apixaban in nephrotic syndrome.
- Trial name
- NCT02599532
- Testing
- apixaban
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Healthy Volunteers, Fasting
Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers
The goal of this clinical trial is to evaluate the pharmacokinetic profiles and bioequivalence, and to determine the safety and tolerability of the TAH3311 Oral Dissolving Film (ODF) 5mg compared with ELIQUIS® (Apixaban) 5mg Oral…
- Conditions
- Healthy Volunteers, Fasting, Fed
- Trial name
- NCT05995119
- Testing
- Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- TAHO Pharmaceuticals Ltd.
Healthy
Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ciraparantag for reversal of anticoagulation induced by different anticoagulant drugs in generally healthy adults as measured primarily…
- Trial name
- NCT04593784
- Testing
- Ciraparantag, Point-of-Care Coagulometer (investigational device)
- Where
- 3 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- AMAG Pharmaceuticals, Inc.
Healthy Volunteer
Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers
The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects.
- Trial name
- NCT06388239
- Testing
- Apixaban 5MG
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- International Bio service
Nephrotic Syndrome, Membranous Nephropathy
A Prospective Multi-dose Study of Apixaban in Subjects With Nephrotic Syndrome
This phase I study is a single arm, multi-dose study that will evaluate steady-state apixaban pharmacokinetics (PK) and pharmacodynamics (PD) in subjects with Nephrotic Syndrome (NS) vs healthy control subjects.
- Trial name
- NCT04278729
- Testing
- Apixaban 5 MG
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation
Phase I Study of MT1011 Injection in Healthy Subjects
This is a single-center, randomized,double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) of MT1011 injection in healthy adult subjects.
- Trial name
- NCT07024160
- Testing
- MT1011
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
N/A - Healthy Subjects
Phase 1 Drug Interaction Study of Apixaban and Atenolol in Healthy Subjects
The purpose of this study is to assess the effect of Atenolol 100 mg on the Pharmacokinetics (PK) of Apixaban and the effect of Apixaban 10 mg on the PK of Atenolol in Healthy subjects.
- Trial name
- NCT02262533
- Testing
- Apixaban, Atenolol
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Drug Drug Interaction (DDI)
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
- Trial name
- NCT07265466
- Testing
- JP-1366 and clopidogrel, JP-1366 and aspirin, JP-1366 and atorvastatin
- Where
- South Korea
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Onconic Therapeutics Inc.
Novel Oral Anticoagulants, NOACs
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants
It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%.
- Conditions
- Novel Oral Anticoagulants, NOACs, Rivaroxaban, Apixaban
- Trial name
- NCT03161496
- Testing
- detection of genotype
- Where
- 17 sites in China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Cui Yimin
Acute Coronary Syndrome
Apixaban + DAPT in Lowering Platelet Reactivity and Thrombin Generation
Investigating Synergistic Effects of Apixaban with Dual Anti-Platelet Therapy (DAPT) in Lowering Platelet Reactivity and Thrombin Generation
- Trial name
- SEARCH (NCT03746782)
- Testing
- Flow Cytrometry; Thrombin Generation Assay
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CirQuest Labs, LLC
Healthy
Phase 2 Study of Apixaban Reversal by Ciraparantag as Measured by WBCT
This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and safety of ciraparantag administered to healthy volunteers anticoagulated with apixaban measuring clotting times using Whole Blood…
- Trial name
- NCT03288454
- Testing
- Ciraparantag, Apixaban
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Cancer Patients, Central Venous Catheter Thrombosis
Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) in Cancer Patients
Cancer patients with Central Venous Catheter (CVC) Associated Deep Vein Thrombosis (DVT) will be treated with Low Molecular Weight Heparin (LMWH) and apixaban. Study duration is 12 weeks.
- Conditions
- Cancer Patients, Central Venous Catheter Thrombosis, Upper Extremity Thrombosis
- Trial name
- NCT03100071
- Testing
- Apixaban
- Where
- 2 sites in Canada
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Michael Kovacs
N/A - Healthy Subjects
Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK) of multiple-dose Digoxin in healthy subjects.
- Trial name
- NCT02262520
- Testing
- Apixaban, Digoxin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb