Pharmacokinetics and Bioequivalence study of Acamprosate calcium enteric coated tablets in Healthy Chinese male Volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TTRCC-14004853

Enrollment

Unknown

Registered

2014-06-26

Start date

2014-07-01

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

Pharmacokinetic Properties

Interventions

trial:Acamprosate calcium enteric coated tablets(newly developed formulation or established branded formulation)

Eligibility

Sex/Gender

Male

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Healthy male chinese volunteers aged from 18 to 40 and with a body mass index between 19–24 kg/m2; a healthy status confirmed by medical history, physical examination, 12-lead ECG, and laboratory tests (hematology, blood biochemistry, hepatic function, urinalysis, hepatitis B surface antigen, tests for alcohol and other drugs of abuse) and nonsmoking status.

Exclusion criteria

Exclusion criteria: any allergic history or history of cardiac, pulmonary, renal, hepatic, gastrointestinal or hematologic abnormality or any other acute or chronic disease. exposure to any investigational medication within 30 days of the first dose of study medication, pregnant or nursing women, women of childbearing potential not using a highly effective method of birth control.

Design outcomes

Primary

Measure	Time frame
plasma drug concentratio;	—

Countries

China

Contacts

Public ContactYongping Qin

luozhu720@sohu.com+86 028-85421606

Outcome results

None listed

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