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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02183285

Enrollment

203

Registered

2014-07-08

Start date

2003-11-30

Completion date

Unknown

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DIETARY_SUPPLEMENTPharmaton PHL 00747 soft gelatine capsules

DIETARY_SUPPLEMENTPharmaton PHL 00747 film-coated tablets

DIETARY_SUPPLEMENTPlacebo film-coated tablets (fct)

DIETARY_SUPPLEMENTPlacebo soft gelatine capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of total drug-related adverse events assessed by the investigator	up to 30 days

Secondary

Measure	Time frame
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
Incidence of all adverse events	up to 30 days
Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale	day 30
Tolerability of the trial medications by the subject	up to 30 days
Overall tolerability assessed by the subject and the investigator on a four-point rating scale	day 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026