Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02181959

Enrollment

138

Registered

2014-07-08

Start date

1998-12-31

Completion date

Unknown

Last updated

2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.

Interventions

DRUGPharmaton® with DMAE

DRUGPharmaton® without DMAE

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy man or woman, between 20 to 70 years * Fit to work * Volunteers have given informed consent and signed the consent form

Exclusion criteria

* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc) * Treatment with other drugs that might interfere with the evaluation of the safety of the test drug * Known hypersensitivity to any ingredients of the study drug * Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive * Drug and alcohol abuse * Participation in another trial * Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)

Design outcomes

Primary

Measure	Time frame
Number of patients with adverse events	up to 60 days
Assessment of overall tolerability rate on a 4-point scale	Day 30 and 60

Secondary

Measure	Time frame
Number of patients with abnormal changes in laboratory parameters	Day 0, 30 and 60
Number of patients with abnormal findings in physical examination	Day 0, 30 and 60

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026