The behaviour of the drug tacrolimus in the stomach of healthy volunteers

Supersaturation and precipitation of tacrolimus in the stomach of healthy volunteers

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002519-17-BE

Enrollment

Unknown

Registered

2016-07-26

Start date

2016-09-12

Completion date

Unknown

Last updated

2017-08-28

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

Conditions

Healthy human volunteers , investigation of the drug's supersaturation behaviour in the stomach

Interventions

Trade Name: Prograft Product Name: Prograft Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Current Sponsor code: FK-506 Other descriptive name: Tacrolimus C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - healthy volunteers- age: 18 - 35 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - disease- acute/chronic GI condition- use of medication- pregnancy- frequent exposure to X-rays during the past year- HIV / HBV / HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: Study the gastric behaviour of tacrolimus in healthy volunteers in fasted and fed state and when co-ingested with other beverages than water.;Secondary Objective: Non applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactDrug Delivery and Disposition

KU Leuven

jari.rubbens@kuleuven.be+3216377307

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026