Trial document




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  DRKS00008766

Trial Description

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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

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Trial Acronym

X-03178-3307

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URL of the Trial

[---]*

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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.

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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.

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Organizational Data

  •   DRKS00008766
  •   2015/06/19
  •   [---]*
  •   no
  •   Approved
  •   15038, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   2015-000974-37 
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Health Condition or Problem studied

  •   healthy subjects
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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
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Other
  •   Crossover
  •   I
  •   No
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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).

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Secondary Outcome

Assess further plasma pharmacokinetics parameter, Safety and tolerability of different
formulations.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/06/23
  •   39
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   55   Years
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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.

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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.

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Addresses

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    • 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
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    • 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
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    • Nuvisan GmbH, Human-pharmakologisches Zentrum
    • Mr.  Denis  Strugala 
    • Wegenerstr. 3
    • 89231  Neu-Ulm
    • Germany
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Sources of Monetary or Material Support

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    • MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs
    • Mr.  PD Dr.  Ullrich  Munzel 
    • Benzstr. 1
    • 61352  Bad Homburg
    • Germany
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    •   0049 6172 888 01
    •   0049 6172 888 2883
    •   [---]*
    •   http://www.mylan.com
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/27
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.