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The clinical research of absorption and pharmacokinetic of Compound Bismuth and Magnesium Granules in Chinese healthy volunteers

The clinical research of absorption and pharmacokinetic of Compound Bismuth and Magnesium Granules in Chinese healthy volunteers

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-14004656
Enrollment
Unknown
Registered
2014-09-21
Start date
2014-06-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Peptic ulcer, Gastritis, Functional dyspepsia

Interventions

WBM:Compound Bismuth and Magnesium Granules

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
25 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1) Age between 20-50 years;2) 7-10 male,7-10 female;3) BMI is controlled between 18.5-23;4)Laboratory tests: the following clinical examination indexes should be normal: ?Glu, BUN, Cr, T-Bil, D-Bil, ALT, AST, TP?ALB; ?HbsAg; ?routine urine test, blood test and fecal test, 12 lead ECG;5)Normal body temperature, pulse and blood pressure;6)No smoking, drinking, and other drug addiction;7)Agreed to participate in this study and signed informed consent;8)To attend all experiment until the end of the study.

Exclusion criteria

Exclusion criteria: 1)Having allergy history; 2) With organic diseases, such as cardiovascular, hepatic, kidney, especial digestive tract disease; 3) Participated in any clinical drug trials or donated blood within 3 months before study; 4) Taking any drugs within 2 weeks before the study or taking drugs containing bismuth 3 months prior to the study; 5) women pregnant or going to be pregnant within 6 months; 6)Healthy subjects unwilling or unable to comply with the test requirements.

Design outcomes

Primary

MeasureTime frame
plasma concentration of bismuth;urine concentration of bismuth;pharmacokinetic parameter;

Countries

China

Contacts

Public ContactFan-dong Meng
mfdzhaotianyu@163.com+86 13681061594

Outcome results

None listed

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