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

NCT ID: NCT02183285

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PHL 00747 capsules

Group Type EXPERIMENTAL

Pharmaton PHL 00747 soft gelatine capsules

Intervention Type DIETARY_SUPPLEMENT

Placebo film-coated tablets (fct)

Intervention Type DIETARY_SUPPLEMENT

PHL 00747 tablets

Group Type EXPERIMENTAL

Pharmaton PHL 00747 film-coated tablets

Intervention Type DIETARY_SUPPLEMENT

Placebo soft gelatine capsules

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

Placebo film-coated tablets (fct)

Intervention Type DIETARY_SUPPLEMENT

Placebo soft gelatine capsules

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Pharmaton PHL 00747 soft gelatine capsules

Intervention Type DIETARY_SUPPLEMENT

Pharmaton PHL 00747 film-coated tablets

Intervention Type DIETARY_SUPPLEMENT

Placebo film-coated tablets (fct)

Intervention Type DIETARY_SUPPLEMENT

Placebo soft gelatine capsules

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1209.1

Identifier Type: -

Identifier Source: org_study_id

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