Phase I healthy volunteer study
Conditions
Interventions
Product Name: Pulmicort Turbohaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Subject has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure · White (Caucasian origin) healthy male/female subjects, aged between 18 and 45 years (inclusive) · Normal body weight as evidenced by a Body Mass Index (BMI) between > or = 18 and 50 kg · Safe contraception in females of childbearing potential during the entire study, which means the use of effective birth-control methods such as hormonal contraceptives for at least 2 months prior to start of screening, double barrier method (condoms and diaphragms) or intra-uterine devices, which were thought to be medically acceptable forms of birth control 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Safety concerns: · History or current evidence of allergies or idiosyncrasy to drugs or food, if considered relevant at the discretion of the investigator · History of allergic reactions to any active or inactive ingredient of the trial medication · History or current evidence of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease within the last 2 years, if considered relevant at the discretion of the investigator · Impairment of blood coagulation · History of malignancy within the past 5 years · Electrocardiogram (ECG) abnormalities of relevance (assessment by investigator, e.g. QTc according to Bazett: males and females > 450 ms, PQ > or = 220 ms) · Relevant (assessment by investigator) abnormalities in clinical chemical, hematological or any other laboratory variables · Chronic or clinically relevant acute infections (assessment by investigator) · Proneness to orthostatic dysregulation, fainting, or blackouts · Positive results in any of the virology tests for HIV-Ab1 or HIV-Ab2, HCV-Ab, HBsAg. · Drug screen positive or not performed · Abuse of alcohol (>2 drinks/day defined according to USDA Dietary Guidelines 2005) or drugs · Pregnant or lactating females · ß-HCG pregnancy test (female subjects) positive or not performed Lack of suitability for the trial: · Treatment with any known CYP3A4-isoenzyme inducing / inhibiting agents (barbiturates, phenothiazines, cimetidine, ketoconazole etc.) and eating Brussels sprout or broccoli and eating grapefruits or star fruits, drinking of star- or grapefruit juice within two weeks prior to the study · Use of any medication (incl. herbal and over-the-counter (OTC) medication) within two weeks before trial drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment period (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives) · Vegetarian diet or other peculiar dietary habits which would preclude the subject’s acceptance of standardized meals · Surgery of the gastrointestinal tract which may interfere with drug absorption · Participation in drug trials within the last 30 days before start of the study (last day of intake of medication – first day of medication in the following study) · Smoking of more than 5 cigarettes daily · Anticipated donation of spermatocytes or oocytes for medically assisted reproduction techniques (ART) within 2 months after the last dose of the present trial · Blood donation within the last 30 days before start of the study Administrative reasons: · Lack of ability or willingness to give informed consent · Anticipated non-availability for study visits/procedures. · Anticipated lack of willingness or inability to cooperate adequately · Vulnerable subjects (e.g. persons kept in detention) · Anticipated lack of ability or willingness to apply safe contraception (female subjects)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ·To assess the free unbound concentration of budesonide in Serum, Muscle tissue, and Subcutaneous adipose tissue;Secondary Objective: · To assess total concentrations (bound and unbound) of budesonide in serum · To assess metabolites of budesonide in serum (if feasible) · To assess safety and tolerability;Primary end point(s): Free unbound concentrations of budesonide as obtained by microdialysis in serum, muscle tissue and subcutaneous adipose tissue | — |
Countries
Austria
Outcome results
None listed