Vitamin K1

Generic Name: Vitamin K1

Brand Names: Aquamephyton, Infuvite, Infuvite Pediatric, Mephyton, Mvi Pediatric, Phytonadione

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₄₆O_₂

CAS Number: 84-80-0

Unique Ingredient Identifier: S5Z3U87QHF

Background: Vitamin K1, also called phylloquinone or phytonadione, is a fat soluble vitamin. Phylloquinone is a cofactor of the enzyme γ-carboxylase, which modifies and activates precursors to coagulation factors II, VII, IX, and X. It is indicated in the treatment of coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by defic...

Indication: Oral phylloquinone is indicated to treat prothrombin deficiency caused by coumarin or indanedione derivatives; and hypoprothrombinemia secondary to antibacterial therapy, salicylates, or obstructive jaundice or biliary fistulas with concomitant bile salt administration.
...

Associated Conditions: Coagulation Disorder, Hypoprothrombinemia, Hemorrhagic disease of the newborn

Associated Therapies: Vitamin supplementation

Clinical Trials

Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Tipranavir solution
Drug: Tipranavir capsule
Drug: Ritonavir capsule
Drug: Caffeine
Drug: Warfarin sodium
Drug: Vitamin K
Drug: Omeprazole
Drug: Dextromethorphan hydrobromide
Drug: Midazolam injection
Drug: Midazolam oral solution
Drug: Digoxin tablet
Drug: Digoxin injection

First Posted Date: 2014-09-18

Last Posted Date: 2014-09-18

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 34

Registration Number: NCT02243553

Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BI 201335 NA
Drug: Caffeine
Drug: Warfarin sodium
Drug: Vitamin K
Drug: Omeprazole
Drug: Dextromethorphan hydrobromide
Drug: Midazolam HCl solution
Drug: Midazolam HCl oral syrup
Drug: Digoxin

First Posted Date: 2014-07-08

Last Posted Date: 2014-07-18

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 23

Registration Number: NCT02182336

Vitamin K1 to Slow Progression of Vascular Calcification in HD Patients

Phase 3

Terminated

Conditions: Cardiovascular Diseases

Interventions: Drug: Vitamin K1

First Posted Date: 2012-12-05

Last Posted Date: 2020-10-08

Lead Sponsor: RWTH Aachen University

Target Recruit Count: 63

Registration Number: NCT01742273

Locations: 🇩🇪
University hospital of Erlangen - Department of Medicine 4, Nephrology and Hypertension, Erlangen, Germany
🇩🇪
Clinical Center of Coburg - Department of Medical Clinic III, Nephrology, Coburg, Germany
🇩🇪
KfH Curatorchip for Dialysis and Renal Transplantation e.V., Stolberg, Germany

and more 9 locations

A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis

Phase 1

Completed

Conditions: Arthritis, Rheumatoid

Interventions: Drug: Sirukumab
Drug: Midazolam
Drug: Warfarin
Drug: Vitamin K
Drug: Omeprazole
Drug: Caffeine

First Posted Date: 2012-07-10

Last Posted Date: 2017-03-07

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 12

Registration Number: NCT01636557

Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients

Phase 2

Completed

Conditions: End-stage Kidney Disease

Interventions: Drug: Microcrystalline Methylcellulose
Drug: Vitamin K1

First Posted Date: 2012-02-08

Last Posted Date: 2021-06-28

Lead Sponsor: Dr. Rachel Holden

Target Recruit Count: 85

Registration Number: NCT01528800

Locations: 🇨🇦
The Ottawa Hospital, Ottawa, Ontario, Canada
🇨🇦
Kingston Health Sciences Centre: Kingston General Hospital Site, Kingston, Ontario, Canada
🇨🇦
London Health Sciences Centre, London, Ontario, Canada

A Study to Explore the Pharmacodynamic Changes When Transitioning From Rivaroxaban to Warfarin in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Rivaroxaban
Drug: Warfarin
Drug: Vitamin K

First Posted Date: 2011-07-22

Last Posted Date: 2017-01-24

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 46

Registration Number: NCT01400646

Vitamin K as Additive Treatment in Osteoporosis

Phase 2

Conditions: Post-menopausal Osteoporosis

Interventions: Drug: placebo
Drug: Menatetrenone (MK4)
Drug: Phylloquinone

First Posted Date: 2010-11-02

Last Posted Date: 2020-02-13

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Target Recruit Count: 105

Registration Number: NCT01232647

Locations: 🇬🇧
Guy's and St Thomas' Hospital NHS foundation Trust, London, United Kingdom
🇬🇧
Osteoporosis Unit, Guy's Hospital, London, United Kingdom

Comparing Different Routes and Doses of Phytonadione (Vitamin K) for Reversing Warfarin Treated Patients With Hip Fracture Before Surgery

Not Applicable

Withdrawn

Conditions: Bleeding
Complications

Interventions: Drug: Phytonadione

First Posted Date: 2009-05-20

Last Posted Date: 2015-06-23

Lead Sponsor: HaEmek Medical Center, Israel

Registration Number: NCT00905229

Locations: 🇮🇱
Haemek Medical Center, Afula, Israel

Nutritional Problems After Lung and Heart Transplantation

Not Applicable

Conditions: Bone Density
Overweight

First Posted Date: 2009-01-22

Last Posted Date: 2011-07-06

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 94

Registration Number: NCT00826254

Locations: 🇳🇴
Rikshospitalet HF, Oslo, Norway

Determinants of Vitamin K Metabolism

Not Applicable

Completed

Conditions: Aging
Osteoporosis

Interventions: Drug: Vitamin K

First Posted Date: 2006-06-13

Last Posted Date: 2023-11-29

Lead Sponsor: Tufts University

Target Recruit Count: 59

Registration Number: NCT00336232

Locations: 🇺🇸
Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, Massachusetts, United States

Drug Development Updates

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