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Effects of aspirin and a blood pressure medicine on the blood concentrations of allopurinol, a common treatment for gout

The effect of low-dose aspirin and/ or hydrochlorothiazide (HCT) on the pharmacokinetics and pharmacodynamics of allopurinol in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000477426
Enrollment
8
Registered
2007-09-21
Start date
2007-07-18
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Gout is an inflammatory condition caused by the deposition of urate crystals in tissues/joints. Allopurinol is a common and effective treatment to prevent gout. Gout predominantly affects the older population who are at risk for cardiovascular disease such as hypertension and heart attack. Low-dose aspirin and hydrochlorothiazide are used for the prevention of such cardiovascular events. Therefore, co-administration of allopurinol and aspirin and/or hydrochlorothiazide is common in older individuals. However, there has been no investigation of this combination of drugs with respect to control of urate concentrations in the body. This study will examine the interaction between allopurinol and aspirin and hydrochlorothiazide.

Interventions

Healthy volunteers not taking any regular medication, including herbal medicines, will be will be treated in a randomised order with a single dose of allopurinol (control; 600 mg), and with allopurinol combined with a single dose of aspirin (100 mg), with a single dose of HCT (25 mg) and with the combination, aspirin and HCT. All drugs will be administered orally. Urine (3 x 2 h sequential collections) and blood samples (3 mid-point blood samples) will be collected over 6 h. Blood and urine wi

Healthy volunteers not taking any regular medication, including herbal medicines, will be will be treated in a randomised order with a single dose of allopurinol (control; 600 mg), and with allopurinol combined with a single dose of aspirin (100 mg), with a single dose of HCT (25 mg) and with the combination, aspirin and HCT. All drugs will be administered orally. Urine (3 x 2 h sequential collections) and blood samples (3 mid-point blood samples) will be collected over 6 h. Blood and urine will be analysed for uric acid and plasma and urinary oxypurinol concentrations. There will be a washout period of 1 week between each treatment.

Sponsors

Professor Richard Day
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion Criteria: 1) Male or female with Body Mass Index (BMI) between 20 and 30 kg/ m 2) Healthy, as determined by a medical examination, medical history and normal biochemical and haematological values.

Exclusion criteria

1) Medical condition or abnormality that, in the opinion of the investigators would preclude him or her from participation, 2) History of cardiovascular disease, diabetes or renal disease, 3) On medications likely to affect urate clearance, including Non Steriodal Anti Inflammatory Drugs (NSAIDs), Angiotensin Converting Enzyme (ACE) inhibitors and lipid lowering drugs, 4) A diet which has the potential to interfere with the study outcomes, e.g. raise uric acid concentrations, and is unwilling to discontinue consuming such food/ drink for the duration of the study, 5) History of substance abuse or drug addiction or consumes more than 21 standard drinks per week, 6) Abnormal laboratory test results (outside 2 standard deviations from the mean)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026