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To observe the effect of dapagliflozin on serum uric acid in healthy men

To observe the effect of dapagliflozin on serum uric acid in healthy men

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013484
Enrollment
Unknown
Registered
2017-11-22
Start date
2018-01-01
Completion date
Unknown
Last updated
2017-11-27

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

Conditions

Uric acid

Interventions

1:Taking placebo 2 weeks
2:Taking 10 mg dapagliflozin 2 weeks

Sponsors

Weishan People's Hospital, Shandong
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Healthy Chinese males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests; 2. Aged 18 to 40 years; 3. BMI 19 to 24 kg/m2 (incl.), body weight=50kg; 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria

Exclusion criteria: 1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance; 2. Any evidence of a clinically relevant concomitant disease; 3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders; 4. Surgery of the gastrointestinal tract (except appendectomy); 5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders; 6. History of relevant orthostatic hypotension, fainting spells or blackouts; 7. Chronic or relevant acute infections; 8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients); 9. within at least one month or intake of drugs with a long half-life ( less than 10 half-lives of the respective drug prior to administration or during the trial; 10. Participation in another trial with an investigational drug within two months prior to administration or during the trial; 11. Smoker; 12. Drinker; 13. Drug abuse; 14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial); 15. Excessive physical activities (within one week prior to administration or during the trial); 16. Any laboratory value outside the reference range that is of clinical relevance; 17. Inability to comply with dietary regimen of trial site; 18. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms).

Design outcomes

Primary

MeasureTime frame
Blood Pressure;ECG;BMI;

Countries

China

Contacts

Public ContactLi Xiaoe

Weishan People's Hospital, Shandong

xeli66@163.com+86 17686106916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026