Bioequivalence and Relative Bioavailability of Mesalazine Enteric-Coated Tablets (Fed State and Fasting)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018107

Enrollment

Unknown

Registered

2018-08-31

Start date

2017-07-19

Completion date

Unknown

Last updated

2018-09-03

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

Conditions

Pharmacokinetics and Bioequivalence Study in Human

Interventions

1:Phase I: Mesalazine Enteric-Coated Tablet 500mg(Vickmans Laboratories Ltd., Hong Kong)

Phase II: Mesalazine Enteric-Coated Tablet 500mg(Dr.Falk Pharma GmbH, Germany)

Phase III: Mesalazine Enteric-Coated Tablet 500mg(Vickmans Laboratories Ltd., Hong Kong)

Phase IV: Mesalazine Enteric-Coated Tablet 500mg(Dr.Falk Pharma GmbH, Germany)

2:Phase I: Mesalazine Enteric-Coated Tablet 500mg(Dr.Falk Pharma GmbH, Germany)

Phase II: Mesalazine Enteric-Coated Tablet 500mg(Vickmans Laboratories Ltd., Hong Kong)

Phase III: Mesalazine Enteric-Coated Tablet 500mg(Dr.Falk Pharma GmbH, Germany)

Phase IV: Mesalazine Enteric-Coated Tablet 500mg(Vickmans Laboratories Ltd., Hong Kong)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female aged more than 18 years; 2. Male subjects weight greater than 50 kg, the female subjects weight greater than 45 kg, BMI 19 to 26; 3. All subjects are voluntary to take part in the trial and signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Abnormalities in general physical examination or laboratory tests; 2. History of cardiovascular, haematological, hepatic, renal, biliary, gastrointestinal, psychological other acute diseases; 3. drug allergies and drug dependence; 4. AIDS and HIV positive;

Design outcomes

Primary

Measure	Time frame
bioequivalence;	—

Countries

China

Contacts

Public ContactZhang Bikui

Institute of Clinical Pharmacy, Central South University

bikui-zh@126.com+86 13973116871

Outcome results

None listed

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