Phase I

Our phase-I services …

In our modern and fully equipped Clinical Pharmacology Unit we run all kinds of phase-I trials under the responsibility of a Clinical Pharmacologist as Medical Director and of an anaesthesiologist being medically in charge of the unit.

… in detail

Our clinical team is experienced in realising all phase-I trials of relevance for your clinical development programme:

• First-in-human / MTD trials
• “Classical” PK trials from single dose to multiple dose also with long hospitalisation phases and with complete urine and faeces sampling
• Drug-drug and drug-food interaction trials
• Studies for characterising absorption windows in the gastrointestinal tract
• Trials with all kinds of devices including inhalative absorption, intravaginal administration under gynaecological control
• Bioavailability / bioequivalence trials under highly standardised conditions also with large sample sizes
• PK trials in special populations

Study population

From healthy subjects of any kind (young, male, female, postmenopausal, elderly etc.) to special populations and symptomatic patients – we manage recruitment challenges successfully and with a high level of reliability: our network of recruiting physicians spread over Thuringia allows us to be successful.

Do not hesitate to contact us for a feasibility assessment of your trial.