Gastrointestinal Tolerance Assessment of T2309 (GATA)

Thea Pharma

Status

Completed

Conditions

Healthy Adult Subjects

Treatments

Other: T2309

Dietary Supplement: Nutrof Total

Study type

Interventional

Funder types

Industry

Identifiers

LT2309-001

Details and patient eligibility

About

Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.

Enrollment

55 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Informed consent signed and dated
Volunteer with no history of gastrointestinal disorders
Volunteer agreeing not to consume a food supplement other than IP during the study period
Registered, or agreeing to be registered, in the National Registry of Healthy Volunteers

Exclusion criteria

Any known or suspected hypersensitivity or allergy
History of or active severe chronic disease or relevant systemic condition incompatible with the study
Pregnancy or breast-feeding or have planned pregnancy in the next 4 months
Childbearing potential woman neither surgically sterilized nor using an adequate contraception
Inability of the subject to understand the study procedures or to give informed consent
Non-compliant subject
Participation in this study at the same time as another clinical investigation/study
Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
Subject being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study site or of the Sponsor's company
Subject not covered by the government health care scheme of the country in which he/she is living
Subject with previous, current or anticipated prohibited treatment