Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults

Summary

The single-center, randomized, open-label, three-period crossover bioavailability study will include 21 subjects who will test three CoQ10 formulations. Subjects will test 3 formulations of single dose CoQ10 within first 3 weeks to assess bioavailability, which will be followed with 2 weeks of continuous administration of one of study formulations to demonstrate and assesse multiple-dose profile of CoQ10.

Conditions

• Bioavailability of Coenzyme Q10

Interventions

DIETARY_SUPPLEMENT

Single dose intervention with Standard product (SP)

hard capsules, 100 mg

DIETARY_SUPPLEMENT

Single dose intervention with Comparative product (CP)

soft-gel capsules, 100 mg

DIETARY_SUPPLEMENT

Single dose intervention with Investigational product (IP)

syrup, 100 mg

DIETARY_SUPPLEMENT

Multiple dose intervention with Standard product (SP)

hard capsules, 100 mg - 14 days

DIETARY_SUPPLEMENT

Multiple dose intervention with Comparative product (CP)

soft-gel capsules, 100 mg - 14 days

DIETARY_SUPPLEMENT

Multiple dose intervention with Investigational product (IP)

syrup, 100 mg - 14 days

Sponsors & Collaborators

• Vizera d.o.o.

  collaborator INDUSTRY

• Valens Int. d.o.o., Slovenija

  collaborator INDUSTRY

• MEDEDUS, Ljubljana, Slovenia

  collaborator UNKNOWN

• Institute of Nutrition, Slovenia (Nutris)

  lead OTHER

Principal Investigators

• Igor Pravst · Nutrition Institute, Ljubljana

• Snežana Kocijančič · MEDEDUS, Ljubljana, Slovenia

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

65 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-29

Primary Completion

2017-10-20

Completion

2017-10-20

Countries

• Slovenia

Study Locations