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.