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OpenTrials
Completed

NCT Number: NCT02181959

Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

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.

Completed

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Key information

Conditions

Healthy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pharmaton® with DMAE

Drug

Pharmaton® without DMAE

Drug

Placebo

Drug

Primary outcomes

  1. Number of patients with adverse events

    Time frame: up to 60 days

  2. Assessment of overall tolerability rate on a 4-point scale

    Time frame: Day 30 and 60

Secondary outcomes

  1. Number of patients with abnormal changes in laboratory parameters

    Time frame: Day 0, 30 and 60

  2. Number of patients with abnormal findings in physical examination

    Time frame: Day 0, 30 and 60

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1999
First posted
Jul 8, 2014
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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