The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of 1 g MaxSimil® fish oil + 200 mg CoQ10. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

The participant will arrive fasted at he research center. After installing a cathether and drawing 5 mL of blood, the participants will be given one of the active comparator or the treatment. The choice of the treatment/comparator will be random. In this arm, the participant will receive 1 dose of 1 g rice bran oil + 200 mg CoQ10. The participant will consume this unique dose with a standardized breakfast. There will thereafter be blood sample collection over 24 h to evaluate the level of omega-3 fatty acids in the plasma and a side effect questionnaire will be administered to monitor side effects.

Healthy

The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form.
Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants.

MaxSimil® fish oil + CoQ10

Rice bran oil + CoQ10

CoQ10 as powder form

Centre de Recherche sur le Vieillissement

Pharmacokinetic Study on Three Formulations of Coenzyme Q10 With Different Carriers

Plasma CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC analyzes, area under the curve (AUC) 0-48 hours will be calculated, as the first parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC analyzes, AUC 0-6 hours (absorption study) will be calculated, as the second parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC analyzes, maximum concentration will be calculated, as the third parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Plasma CoQ10 levels will be measured by high-performance liquid chromatography (HPLC), each sample being performed randomly blindly. After HPLC analyzes, time when the maximum concentration is reached will be calculated, as the fourth parameter of the PK. Statistical analyzes will then be performed on this PK parameter.

Mélanie Plourde

Principal investigator

Double-blind controlled-randomized pharmacokinetic (PK) study with crossover design (15 men and 15 women), with a minimum of 6 days between treatments

Neither the participant nor the research nurse will know the administration order of the different treatments administered. All plasma samples collected during the research project will be anonymized i.e. it will not be possible to identify the participant by his name since a number will be assigned to him. The code key linking the participant's name to his number will be stored, with access restricted to those designated by the principal investigator. The data file is also protected by a password.

ferrous bisglycinate chelate 1 tablet daily

ferrous bisglycinate chelate 2 tablets daily

Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.

Ferrous Bisglycinate Chelate 60 mg 1 Once-daily

Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.

Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily

Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.

Ferrous Ascorbate 100 mg 1 Once-daily

Total

Sex: Female, Male

Region of Enrollment

At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.

Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily)

Mean Change in Hb From Baseline to 8 Weeks

At fortnightly visits, blood was collected for Hb. Number of participants who achieved a target Hb of more than or equal to 12 gm/dL is presented.

Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment

At fortnightly visits, blood was collected for Hb. Mean change in Hb at Week 2, Week 4, Week 6 and Week 8 are presented.

Mean Change in Hb During 8 Weeks Therapy

The comparison in percentage of participants with gastrointestinal side effects during 8 week treatment period is reported. Gastrointestinal side effects during 8 weeks treatment included abdominal discomfort, gastritis, nausea, dyspepsia, change in bowel habit, constipation, faeces discolored, diarrhea and flatulence.

Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate

Overall Study

GSK Response Center

Haematopoiesis

ferrous ascorbate

ferrous bisglycinate chelate 1 OD

ferrous bisglycinate chelate 2 OD

GSK Investigational Site

A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.

A Multicentre, Randomized, Laboratory-blinded, Parallel-group Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.

ascorbate/fatigue

Pharmacokinetic Study on Three Formulations of Coenzyme Q10 With Different Carriers

A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.

Study of High-Dose Intravenous (IV) Vitamin C Treatment in Patients With Solid Tumors

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