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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Dietary Supplement: Placebo film-coated tablets (fct); Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsules; Dietary Supplement: Pharmaton PHL 00747 film-coated tablets; Dietary Supplement: Placebo soft gelatine capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183285

1209.1

Details and patient eligibility

About

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

Enrollment: 203 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 3 patient groups, including a placebo group

PHL 00747 capsules

Experimental group

Treatment:

Dietary Supplement: Pharmaton PHL 00747 soft gelatine capsules

Dietary Supplement: Placebo film-coated tablets (fct)

PHL 00747 tablets

Experimental group

Treatment:

Dietary Supplement: Pharmaton PHL 00747 film-coated tablets

Dietary Supplement: Placebo soft gelatine capsules

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo film-coated tablets (fct)

Dietary Supplement: Placebo soft gelatine capsules