Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Pharmaton® without DMAE; Drug: Pharmaton® with DMAE; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02181959

1114.10

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 3 patient groups, including a placebo group

Pharmaton® with DMAE

Experimental group

Treatment:

Drug: Pharmaton® with DMAE

Pharmaton® without DMAE

Active Comparator group

Treatment:

Drug: Pharmaton® without DMAE

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo