Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential

Study Overview
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Brief Summary
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To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets

Official Title
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A 30 Day, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre Safety Trial to Evaluate the Tolerability Profile of Pharmaton PHL 00747 Soft Gelatine Capsules (Multivitamin, Multimineral + Omega-3 Fatty Acids) 1/Day p.o. and Pharmaton PHL 00747 Film-coated Tablets (Multivitamin, Multimineral Without Omega-3 Fatty Acids) 1/Day p.o. in Healthy, Young Female Subjects of Child-bearing Potential

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsules
* Dietary Supplement: Pharmaton PHL 00747 film-coated tablets
* Dietary Supplement: Placebo film-coated tablets (fct)
* Dietary Supplement: Placebo soft gelatine capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female out-patients of child-bearing potential Ages ranging between 18 and 40 years Willing and able to give written informed consent in accordance to Good Clinical Practice (GCP) and local legislation prior to participation in the study Exclusion Criteria: Contraindications to the use of any of the trial ingredients Known hypersensitivity to any of the ingredients Alcohol- or drug-addiction Currently participation in another trial, or has participated in a trial within the previous 30 days Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections) Already taking other mult-vitamin products during the last 2 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PHL 00747 capsules<br> | Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsules<br> <br> Dietary Supplement: Placebo film-coated tablets (fct)<br> <br> |
| Experimental: PHL 00747 tablets<br> | Dietary Supplement: Pharmaton PHL 00747 film-coated tablets<br> <br> Dietary Supplement: Placebo soft gelatine capsules<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo film-coated tablets (fct)<br> <br> Dietary Supplement: Placebo soft gelatine capsules<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of total drug-related adverse events assessed by the investigator |  | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |