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Lafutidine film coated tablets (10 mg) study on healthy human

Bioequivalence study of Lafutidine 10 mg film coated tablets

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/06/005928
Enrollment
28
Registered
2015-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Lafutidine 10 mg: Lafutidine 10 mg, orally once a day for one day (Single dose) Control Intervention1: Stogar 10 mg: Lafutidine 10 mg, orally once a day for one day(single dose)

Sponsors

Emcure Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age & Gender: Between 18 t0 45 years

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
C max,AUC 0-t, AUC 0-infTimepoint: 0.00 Hrs, 0.25 Hrs, 0.75 Hrs, 1.00 Hrs, 1.75 Hrs, 2.00 Hrs, 2.50 Hrs, 3.00 Hrs, 4.00 Hrs, 5.00 Hrs, 6.00 Hrs, 8.00 Hrs, 10.00 Hrs, 12.00 Hrs, 16.00 Hrs, 18.00 Hrs, 24.00 Hrs

Secondary

MeasureTime frame
Tmax, T1/2, Kel Timepoint: 0.00 Hrs, 0.25 Hrs, 0.75 Hrs, 1.00 Hrs, 1.75 Hrs, 2.00 Hrs, 2.50 Hrs, 3.00 Hrs, 4.00 Hrs, 5.00 Hrs, 6.00 Hrs, 8.00 Hrs, 10.00 Hrs, 12.00 Hrs, 16.00 Hrs, 18.00 Hrs, 24.00 Hrs

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Therapeutic Drug Monitoring Laboratory

spmtdmlab@gmail.com

Outcome results

None listed

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