NCT03819491

Bioavailability Study of COQUN ORAL FORMULATION

Bioavailability Study of COQUN ORAL FORMULATION (CoQ10) Administered in Healthy Adults (CoQ10-01)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: VISUfarma SpA · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of the study is to evaluate the best dosage for COQUN ORAL FORMULATION in order to reach a level of plasma concentration which might assure its antioxidant effect if taken on a regular basis.

Detailed description

The study will include 24 healthy subjects who will test the CoQ10 formulation. All 24 subjects will test a single dose of 100mg CoQ10 in 1 day to assess bioavailability, which will be followed by a one week wash-out period and then by a 4 week period of continuous administration of COQUN ORAL FORMULATION in parallel groups (1:1): patients will be divided in the continuous treatment period into two groups, one group of 12 patients with intake of 100mg OD, the other one group of 12 patients with intake of 100mg BID, in order to assess multiple-dose profile of COQUN ORAL FORMULATION. Patients will have to fast the night before enrolment, for at least 10 hours. Patients will be requested to fill in a short diary in the multidose phase, on a daily basis, for confirming the product correct intake, and informing on any experienced adverse event and eventual medication taken for its solving.

Conditions

• Male & Female Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	COQUN ORAL FORMULATION	COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®

Timeline

• Start date: 2018-06-22
• Primary completion: 2018-08-29
• Completion: 2018-08-29
• First posted: 2019-01-28
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

1 site across 1 country: Romania