A comparison of the plasma levels and safety of coenzyme Q10 from 4 different formulations in healthy adult volunteers.

Phase 1

Completed

• Conditions: CoQ10 deficiency; Diet and Nutrition - Other diet and nutrition disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12616001527459
• Lead Sponsor: Medlab Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1) Participants > 18 years of age at time of entry on study
2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
3) Participants agree to undergo venipuncture on multiple occasions or have a catheter inserted
4) Participants agree to adhere to the study protocol
5) No history of any chronic diseases

Exclusion Criteria

1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, clinical chemistry, haematology, urinalysis, vital signs
2) Any chronic diseases
3) Alcohol abuse
4) Pregnant or nursing an infant
5) Have not been prescribed (medications) or have administered Coenzyme Q10 or any other supplement or vitamin or mineral or herbal medicine in the last week (note: participation will include a 1 week washout period)
6) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant
7) The use of illicit drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CoQ10 plasma serum measurement [Blood draws at baseline (0), 30, 60, 120, 180, 240 and 360 minutes via cannulation]

Secondary Outcome Measures

Name	Time	Method
Safety - Documentation of any adverse events. Side effects may include: stomach upset, loss of appetite, nausea, vomiting, and diarrhoea. CTC to report participants post administration by direct observation[Clinical Trial Coordinator to document any adverse events: subject to participant. Continuous monitoring after dose administered to 24 hours post administration.]