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.
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
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.
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.
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.
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
End Stage Renal Disease
Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis
The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis.
- Trial name
- NCT01340586
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Food Effect Study For Apixaban Commercial Image Tablets
To evaluate the effect of food on the pharmacokinetics of apixaban administered as commercial image tablets.
- Trial name
- NCT01437839
- Testing
- Apixaban
- Where
- Singapore
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Pfizer
Anticoagulant Therapy
Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation.
- Trial name
- PHAPOCU (NCT05491460)
- Testing
- Apixaban 5 MG Tab, Dabigatran 150 MG Tab, Edoxaban 60Mg Tab
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Doasense GmbH
Thrombosis
Bioavailability of Apixaban Crushed Tablet
The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.
- Trial name
- NCT02101112
- Testing
- Apixaban
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
- Trial name
- NCT02034565
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
Bioavailability of Apixaban Sprinkle Compared to Apixaban Capsules
The purpose of this study is to evaluate the absorption of apixaban (BMS-562247) into the bloodstream of healthy volunteers, when administered as sprinkle capsules compared to tablets.
- Trial name
- NCT03509883
- Testing
- Drug: Apixaban sprinkle capsules, Experimental: Apixaban tablets followed by apixaban sprinkle capsules
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Venous Thromboembolism
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).
- Trial name
- NCT02912234
- Testing
- Apixaban, Clarithromycin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb