Trial document

drksid header


Trial Description

start of 1:1-Block title


An open randomized single dose cross-over study to investigate the relative bioavailability (BA) of different formulations containing crystalline glucosamine sulphate: Film-coated tablet (dona® 750 mg) and oral soluble powder formulation presented as a sachet (dona® 1500 mg) in healthy subjects under different fasted and fed conditions

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In this study the glucosamine levels in blood will be compared after the ingestion of different formulations as dona® 750 film-coated tablets and dona® 1500 mg administerd as a drinking solution under fasted and fed conditions. To this end, study participants aged 18 to 55 years will be invited for several study periods to the study center. Blood samples at various time points before and after taking the study medication will be taken. The blood samples will be analyzed for glucosamine levels; blood levels after taking the tablets will be compared with that of the drinking solutions.
Glucosamine is an endogenous substance, a normal constituent of cartilage matrix and the socalled glycosaminoglycans in the joint fluid. It is approved since decades and is used for the relief of symptoms in mild to moderate osteoarthritis (degenerative joint disease) of the knee.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In this study the relative bioavailability of dona 750 mg film-coated tablets and dona 1500 mg Powder for preparation of an Oral Solution is investigated (active ingredient crystalline glucosamine sulphate for both formulations). The study is monocentric, open, randomized, using a cross-over design and involve healthy subjects under fed and fasting conditions. The appropriate study population consists of healthy men and women aged 18 to 55 years. After an interim analysis further subjects will be randomized.
Crystalline Glucosamine sulphate from the group of SYSADOAs (Symptomatic Slow Acting Drugs in Osteo-arthritis) is a drug approved since years and has a well shown and proved efficacy and safety profile. Crystalline Glucosamine sulphate is used for the treatment of osteoarthritis.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008766
  •   2015/06/19
  •   [---]*
  •   no
  •   Approved
  •   15038, Ethik-Kommission der Bayerischen Landesärztekammer
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2015-000974-37 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   healthy subjects
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   film-coated dona® tablets, single-dose administration of crystalline glucosamine sulphate p.o.
  •   dona® powder for oral solution for a single-dose administration of 1500 mg glucosamine hemisulphate
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Other
  •   Crossover
  •   I
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Assess further plasma pharmacokinetics parameter, Safety and tolerability of different

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Actual
  •   2015/06/23
  •   39
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   55   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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 β-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.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Head of Clinical Affairs Meda
    • Mr.  PD Dr.  Ullrich  Munzel 
    • Benzstr. 1
    • 61352  Bad Homburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Clinical Affairs Meda
    • Ms.  Dr. rer. nat.  Ursula  Petzold 
    • Benzstr. 1
    • 61352  Bad Homburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Nuvisan GmbH, Human-pharmakologisches Zentrum
    • Mr.  Denis  Strugala 
    • Wegenerstr. 3
    • 89231  Neu-Ulm
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs
    • Mr.  PD Dr.  Ullrich  Munzel 
    • Benzstr. 1
    • 61352  Bad Homburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0049 6172 888 01
    •   0049 6172 888 2883
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting complete, follow-up complete
  •   2016/05/27
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.