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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: 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

• Registration Number: NCT02183285
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2004-03
• Status Verified: 2014-01
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Last Update Submitted: 2014-07-04
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PHL 00747 capsules	Pharmaton PHL 00747 soft gelatine capsules	-
PHL 00747 capsules	Placebo film-coated tablets (fct)	-
PHL 00747 tablets	Pharmaton PHL 00747 film-coated tablets	-
PHL 00747 tablets	Placebo soft gelatine capsules	-
Placebo	Placebo film-coated tablets (fct)	-
Placebo	Placebo soft gelatine capsules	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in vital signs (blood pressure and heart rate)	up to 30 days
Tolerability of the trial medications by the subject	up to 30 days
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
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