Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01638143
Other study ID # 10-3-017
Secondary ID
Status Completed
Phase N/A
First received July 9, 2012
Last updated July 10, 2012
Start date November 2010
Est. completion date August 2011

Study information

Verified date July 2012
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.


Description:

Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy men and women, aged between 20 and 40 years

- Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)

- Stable body weight (weight gain or loss < 3 kg in past 3 mo)

- Written consent to take part in the study

- Agreement to adhere to dietary restrictions required by the protocol

Exclusion Criteria:

- Abuse of drugs and/or alcohol

- Use of vitamin supplements containing vitamin K

- Soy allergy

- Pregnancy

- a history of) metabolic or gastrointestinal diseases including hepatic disorders

- Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure

- Use of oral anticoagulants

- Corticoid treatment

- Subjects with anaemia or subjects who recently donated blood or plasma

- Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
MenaQ7 M-1500 capsules
The study participants will receive three different types of capsules as a single dose (75 µg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
Gnosis P-1000 capsules
The study participants will receive three different types of capsules as a single dose (75 µg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
Gnosis M-1500 capsules
The study participants will receive three different types of capsules as a single dose (75 µg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Locations

Country Name City State
Netherlands VitaK BV / Maastricht University Medical Center Maastricht

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary MK-7 absorption profiles The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles. 9 weeks No
See also
  Status Clinical Trial Phase
Completed NCT03705533 - Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State Phase 1
Completed NCT04938856 - Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions Phase 1
Completed NCT03646331 - Bioequivalence of Imeglimin Tablet Formulations Phase 1
Completed NCT04564456 - A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05197517 - Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition Phase 1
Completed NCT03702894 - Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions Phase 1
Withdrawn NCT02894515 - Bioequivalence Study of Idalopirdine in Healthy Subjects Phase 1
Completed NCT03018015 - Ibuprofen Bioavailability Trial With Oral Single Dose Administration. Phase 1
Completed NCT02206295 - Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg Phase 1
Completed NCT01331993 - A Bioequivalence Study to Compare VIMOVO Manufactured at AstraZenca AB to VIMOVO Manufactured by Patheon Pharmaceuticals and Marketed Enteric-coated Naproxen Formulation Phase 1
Completed NCT01260805 - A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers. Phase 1
Recruiting NCT06066112 - Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body Phase 1
Completed NCT05477810 - Bioequivalence of a Single-dose of 12 mg IVERMECTIN as Orally Disintegrating Mini Tablets Versus a Single-dose of 12 mg Regular IVERMECTIN Tablets in Healthy Adults Under Fasting Conditions Early Phase 1
Completed NCT04546256 - A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers Phase 1
Completed NCT05083325 - Bioavailability of Oseltamivir Phosphate 75 mg With Regards to Reference Product Phase 1
Completed NCT05061901 - Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions Phase 1
Recruiting NCT04138888 - A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions Phase 1
Completed NCT05145621 - Oral Bio-equivalence Study Phase 1
Completed NCT06124560 - Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions. Phase 1
Completed NCT03340753 - Bioavailability of KBP-5074 Tablet vs Capsule Formulations Phase 1