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Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kiddi® Pharmaton Fizz, effervescent tablets | Experimental | with reduced amount of minerals |
|
| Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula | Active Comparator |
| |
| Comparator product | Active Comparator | in the form of a product that is a market leader |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kiddi® Pharmaton Fizz, effervescent tablets | Drug |
| ||
| Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of total drug-related adverse events | up to 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all individual drug-related adverse events | up to 19 days | |
| Assessment of overall tolerability and acceptance on a 4-point verbal rating scale | up to day 19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
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| Comparator product | Drug | active substances: Vitamin A, Vitamin B1, Vitamin B2, Vitamin B5, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Manganese, Copper, Calcium, Magnesium, Phosphorous, Iron, Zinc, Sodium, Molybden |
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