Bioavailability and Pharmacokinetics
Conditions
Keywords
glucosamine, crystalline, pharmacokinetics, bioavailability
Brief summary
This study aims to compare the pharmacokinetics and bioavailability of crystalline glucosamine sulfate and regular glucosamine sulfate using a double-blind, randomized, crossover design.
Interventions
A maximum single dose of 1500mg of glucosamine sulfate in a caplet.
A maximum single dose of 1500mg of glucosamine sulfate in hard gel capsules.
Sponsors
Study design
Eligibility
Inclusion criteria
* Male or female aged 21- 65 years * Healthy, good physical condition * Voluntary, written, informed consent to participate in the study.
Exclusion criteria
* Serious acute or chronic diseases e.g. liver, kidney, or gastrointestinal diseases * Use of medications affecting glucosamine metabolism * Known allergies to shellfish or glucosamine * Pregnancy or breastfeeding * Participation in another investigational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC: the area under the concentration-time curve | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested glucosamine sulfate in healthy adult volunteers and compare the Area under the plasma concentration versus time curve (AUC) with that of other capsules containing glucosamine sulfate. |
| Cmax: maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested glucosamine sulfate in healthy adult volunteers and compare the peak plasma concentration (Cmax) with that of other capsules containing glucosamine sulfate. |
| Tmax: the time point of maximum plasma concentration | 0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose) | To determine the gastrointestinal absorption of orally ingested glucosamine sulfate in healthy adult volunteers and compare the time point of maximum plasma concentration (Tmax) with that of other capsules containing glucosamine sulfate. |
Countries
Canada