DRKS00008766CompletedPhase 1
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 - X-03178-3307
MEDA Pharma GmbH & Co. KG (a Mylan company), Scientific Affairs, Head of Clinical Affairs Meda0 sites39 target enrollmentStarted: June 19, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 39
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- All
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
- •- 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.
Investigators
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