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OpenTrials
Completed

NCT Number: NCT02183285

Tolerability of Pharmaton PHL 00747 in Healthy, Young Female Subjects of Child-bearing Potential

To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets

Completed

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy female out-patients of child-bearing potential
  • Ages ranging between 18 and 40 years
  • Willing and able to give written informed consent in accordance to Good Clinical Practice (GCP) and local legislation prior to participation in the study

Exclusion criteria

  • Contraindications to the use of any of the trial ingredients
  • Known hypersensitivity to any of the ingredients
  • Alcohol- or drug-addiction
  • Currently participation in another trial, or has participated in a trial within the previous 30 days
  • Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
  • Already taking other mult-vitamin products during the last 2 weeks

Treatment and study plan

Pharmaton PHL 00747 soft gelatine capsules

Dietary Supplement

Pharmaton PHL 00747 film-coated tablets

Dietary Supplement

Placebo film-coated tablets (fct)

Dietary Supplement

Placebo soft gelatine capsules

Dietary Supplement

Primary outcomes

  1. Incidence of total drug-related adverse events assessed by the investigator

    Time frame: up to 30 days

Secondary outcomes

  1. Incidence of all adverse events

    Time frame: up to 30 days

  2. Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)

    Time frame: up to 44 days

  3. Changes from baseline in vital signs (blood pressure and heart rate)

    Time frame: up to 30 days

  4. Overall tolerability assessed by the subject and the investigator on a four-point rating scale

    Time frame: day 30

  5. Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale

    Time frame: day 30

  6. Tolerability of the trial medications by the subject

    Time frame: up to 30 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A 30 Day, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre Safety Trial to Evaluate the Tolerability Profile of Pharmaton PHL 00747 Soft Gelatine Capsules (Multivitamin, Multimineral + Omega-3 Fatty Acids) 1/Day p.o. and Pharmaton PHL 00747 Film-coated Tablets (Multivitamin, Multimineral Without Omega-3 Fatty Acids) 1/Day p.o. in Healthy, Young Female Subjects of Child-bearing Potential

Important dates

Study start
2003
Primary completion
2004
First posted
Jul 8, 2014
Registry last updated
Jul 8, 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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