Overview

Pharmaton Upgrade in Improving Mental Performance and Decreasing Fatigue

Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
0
Participant gender:
All
Summary
To assess the efficacy and safety of Pharmaton? PHL 00749 in improving cognitive function and allevi ating mental and physical stress in healthy male and female subjects leading demanding lifestyles.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Criteria
INCLUSION CRITERIA Healthy male and female subjects in regular employment, aged between 20
and 50 y ears. Subjects who give written informed consent in accordance with GCP and local
legi slation.

EXCLUSION CRITERIA Subjects who present with clinical depression. Subjects showing evidence
of dementia. Clinically relevant abnormalities in medical history or examination. Subjects
who have participated in a clinical study within 3 months prior to the start of the study.
History of drug and/or alcohol abuse. Subjects who smoke more than 10 cigarettes per day.
Subjects who in the opinion of the Investigator are heavy users of other tobacco or
nicotine products (e.g. snuff, chewing tobacco, nicotine patches, nicotine g um, etc.).
Subjects who have a history of food and/or drug allergies relevant to the study compound.
Clinically relevant deviation from normal of any finding during pre-study medica l
screening. Subjects who are unable to perform the cognitive tests. Subjects currently
taking a cognition enhancing substance, including any Ginkgo, ginseng or guarana product.
Any subject regularly taking a medication who might stop doing so at some time d uring the
active dosing phase. Pregnant or lactating women or female subjects of child-bearing
potential not us ing adequate means of birth control (condoms, contraceptive pills, IUDs,
sterili sation). Subjects already taking other multi-vitamin products during the last 2
weeks. Healthy subjects who are regularly taking drugs which act on the Central Nervous
System (CNS).