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Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02181959
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Pharmaton® with DMAE Drug: Pharmaton® without DMAE Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)
Study Start Date : December 1998
Actual Primary Completion Date : April 1999

Arm Intervention/treatment
Experimental: Pharmaton® with DMAE Drug: Pharmaton® with DMAE
Active Comparator: Pharmaton® without DMAE Drug: Pharmaton® without DMAE
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02181959    
Other Study ID Numbers: 1114.10
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014