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Bioequvalence research of Mycophenolate Sodium Enteric-coated Tablets in healthy people

Bioequvalence research of Mycophenolate Sodium Enteric-coated Tablets in healthy people

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062325
Enrollment
Unknown
Registered
2022-08-01
Start date
2022-07-18
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

Healthy people

Interventions

fasting condition:Mycophenolate Sodium Enteric-coated Tablets
fed condition:Mycophenolate Sodium Enteric-coated Tablets

Sponsors

Yue Bei People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (1)Healthy male Chinese adults, aged 18 or older; (2)Body mass indexes (BMIs) ranging from 19 to 26 kg/m2, and weights higher than 50kg; (3)Willing to participate the trial and signed informed consent forms.

Exclusion criteria

Exclusion criteria: 1)smoke more than five cigarettes per day; 2)pregnant women or nursing mother; 3)had history of hepatic, cardiovascular, gastrointestinal or renal disease; 4)had condition of biliary obstructive disorders; 5)had condition of severe diseases; 6)hepatic impairment; 7)had hypersensitive to telmisartan; 8)had history of alcohol; 9)drug abuse within 12 months prior to screening; 10)had received any other medication within fourteen days prior to the start of study; 11)participated in any clinical study within 3 months prior to the screening; 12)donation or loss more than 300 mL of blood within 3 months prior to the screening; 13)take other medicines or food supplementary or vitamins within 14 days before first study drug administration.

Design outcomes

Primary

MeasureTime frame
Cmax;AUC0-t;AUC0-8;

Countries

China

Contacts

Public ContactWenmao Fan
418681770@qq.com+86 0751 6913882

Outcome results

None listed

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