NCT02183285

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P50-P75 for phase_3 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

July 4, 2014

Last Update Submit

July 4, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    up to 30 days

Secondary Outcomes (6)

  • Incidence of all adverse events

    up to 30 days

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

    up to 44 days

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

    up to 30 days

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

    day 30

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

    day 30

  • +1 more secondary outcomes

Study Arms (3)

PHL 00747 capsules

EXPERIMENTAL
Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsulesDietary Supplement: Placebo film-coated tablets (fct)

PHL 00747 tablets

EXPERIMENTAL
Dietary Supplement: Pharmaton PHL 00747 film-coated tabletsDietary Supplement: Placebo soft gelatine capsules

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo film-coated tablets (fct)Dietary Supplement: Placebo soft gelatine capsules

Interventions

Pharmaton PHL 00747 soft gelatine capsulesDIETARY_SUPPLEMENT
PHL 00747 capsules
Pharmaton PHL 00747 film-coated tabletsDIETARY_SUPPLEMENT
PHL 00747 tablets
Placebo film-coated tablets (fct)DIETARY_SUPPLEMENT
PHL 00747 capsulesPlacebo
Placebo soft gelatine capsulesDIETARY_SUPPLEMENT
PHL 00747 tabletsPlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 8, 2014

Study Start

November 1, 2003

Primary Completion

March 1, 2004

Last Updated

July 8, 2014

Record last verified: 2014-01