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To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHL 00747 capsules | Experimental |
| |
| PHL 00747 tablets | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaton PHL 00747 soft gelatine capsules | Dietary Supplement |
| ||
| Pharmaton PHL 00747 film-coated tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of total drug-related adverse events assessed by the investigator | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all adverse events | up to 30 days | |
| Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL) | up to 44 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Dietary Supplement |
|
| Placebo film-coated tablets (fct) | Dietary Supplement |
|
| Placebo soft gelatine capsules | Dietary Supplement |
|
| Changes from baseline in vital signs (blood pressure and heart rate) | up to 30 days |
| Overall tolerability assessed by the subject and the investigator on a four-point rating scale | day 30 |
| Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale | day 30 |
| Tolerability of the trial medications by the subject | up to 30 days |