Glucosamine Sulfate Bioavailability

NCT06971484 | Completed

• 1 other identifier: 2022-11-002GS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability and Pharmacokinetics

Keywords

glucosamine; crystalline; pharmacokinetics; bioavailability

Outcome Measures

Primary Outcomes (3)

• AUC: the area under the concentration-time curve

  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.

  0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

• Cmax: maximum plasma concentration

  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.

  0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

• Tmax: the time point of maximum plasma concentration

  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.

  0 (baseline; pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 hours (post-dose)

Study Arms (2)

Crystalline glucosamine sulfate

EXPERIMENTAL

Participants receive their treatment of crystalline glucosamine sulfate at a total dose of 1500 mg of glucosamine sulfate. Treatments are consumed with a glass of water followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used.

Dietary Supplement: Crystalline glucosamine sulfate

Regular glucosamine sulfate

EXPERIMENTAL

Participants receive their treatment of regular glucosamine sulfate at a total dose of 1500 mg of glucosamine sulfate. Treatments are consumed with a glass of water followed by a standardized breakfast (diet-controlled condition). Capillary whole blood samples are collected at different time points up to 24 hours post-dose. A washout period of 1 week between each treatment is used.

Dietary Supplement: Regular glucosamine sulfate

Interventions

Crystalline glucosamine sulfate DIETARY_SUPPLEMENT

A maximum single dose of 1500mg of glucosamine sulfate in a caplet.

Crystalline glucosamine sulfate

Regular glucosamine sulfate DIETARY_SUPPLEMENT

A maximum single dose of 1500mg of glucosamine sulfate in hard gel capsules.

Regular glucosamine sulfate

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 21- 65 years
• Healthy, good physical condition
• Voluntary, written, informed consent to participate in the study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Isura: lead

Study Sites (1)

ISURA

Burnaby, British Columbia, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: January 6, 2025
• Primary Completion: March 28, 2025
• Study Completion: April 30, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)