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 deficiency or interference in the activity of vitamin K.

Phylloquinone has been synthesized since at least 1939, and was approved by the FDA prior to 1955.

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.

Parenteral (intravenous, intramuscular, and subcutaneous) phylloquinone is indicated to treat coagulation disorders due to faulty formation of coagulation factors II, VII, IX, and X caused by vitamin K deficiency or some interference with vitamin K activity. These indications include the above indications as well as hypoprothrombinemia secondary to sprue, ulcerative colitis, celiac disease, intestinal resection, pancreatic cystic fibrosis, or regional enteritis; or hypoprothrombinemia caused by interference with vitamin k metabolism.

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

Associated Therapies: Vitamin supplementation

Clinical Trials

Pharmacokinetic Drug-Drug Interaction Study of Rucaparib

Phase 1

Completed

Conditions: Neoplasms

Interventions: Drug: Caffeine
Drug: Warfarin
Drug: Omeprazole
Drug: Midazolam
Drug: digoxin
Drug: Vitamin K
Drug: Rucaparib

First Posted Date: 2016-04-15

Last Posted Date: 2023-06-09

Lead Sponsor: pharmaand GmbH

Target Recruit Count: 17

Registration Number: NCT02740712

Locations: 🇵🇱
BioVirtus Research Site, Kajetany, Mokra 7, Poland
🇵🇱
Zachodniopomorskie Centrum Onkologii Centrum Innowacji, Szczecin, Poland
🇵🇱
Med Polonia, Poznan, Poland

Vitamin K Supplementation in Patients on Hemodialysis

Phase 2

Completed

Conditions: End Stage Renal Failure on Dialysis
Atrial Fibrillation

Interventions: Drug: vitamin K1

First Posted Date: 2014-12-24

Last Posted Date: 2018-02-06

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 3

Registration Number: NCT02324686

Locations: 🇨🇦
University Health Network, Toronto, Ontario, Canada

Study to Evaluate the Effect of Multiple Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Warfarin, Omeprazole, Caffeine, and Dextromethorphan in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BIRT 2584 XX
Drug: Warfarin sodium
Drug: Omeprazole
Drug: Dextromethorphan hydrobromide
Drug: Caffeine
Drug: Midazolam hydrochloride
Drug: Vitamin K1

First Posted Date: 2014-10-06

Last Posted Date: 2014-10-06

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 20

Registration Number: NCT02256813

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

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