healthy subjects
Conditions
Interventions
Group 1: film-coated dona® tablets, single-dose administration of crystalline glucosamine sulphate p.o.
Group 2: dona® powder for oral solution for a single-dose administration of 1500 mg glucosamin
Sponsors
MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Head of Clinical Affairs Meda
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female of any ethnic origin. 2. Age range from 18 to 55 years inclusive. 3. Body mass index (BMI) from 18.5 to 30.0 kg/m2 inclusive. 4. Written informed consent.
Exclusion criteria
Exclusion criteria: - History of allergic reaction or hypersensitivity to glucosamine or excipients of the study medication. - The oral soluble powder formulation contains aspartame and is therefore contraindicated in patients with phenylketonuria. - History of diabetes mellitus or impaired mono-/disaccharides tolerance. - Positive ß-HCG pregnancy test, established pregnancy, or breast-feeding at screening or during the study, or planned pregnancy - Clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrine, haematological, metabolic, neurological or psychiatric, or any other significant diseases, or significant finding, which may interfere with the pharmacokinetics of drugs. - Clinically relevant significant laboratory findings that, in the opinion of the investigator, would preclude inclusion in the trial. - Chronic or clinically relevant acute infections, febrile disease or any acute illness two weeks prior to Screening. - Electrocardiogram (ECG) abnormalities of clinical relevance - Abnormal vital signs (heart rate, blood pressure, and pulse rate). - History of malignancy within the past five years. - Continuous or regular use of any concomitant medication - Consumption of food or food supplements interferring with pharmacokinetics - Exposure to any CYP3A4 inhibiting or inducing diets or beverages. - Presence or history of drug or alcohol abuse, or consumption of significant amounts of alcoholic bevarages or cigerattes/day. - Blood donation within the last 2 months prior to study. - Lack of ability or willingness to give informed consent or to co-operate adequately.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative bioavailability will be assessed on the maximum baseline-corrected plasma concentration Cmax and the baseline-corrected Area under the concentration time curve (AUC0-tlast). | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess further plasma pharmacokinetics parameter, Safety and tolerability of different formulations. | — |
Countries
Germany
Contacts
Public ContactDenis Strugala
Nuvisan GmbH, Human-pharmakologisches Zentrum
Outcome results
None listed