A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet

B

Boryung

Status and phase

Completed
Phase 1

Conditions

Gastric Ulcer

Treatments

Drug: Irsogladine maleate
Drug: Lafutidine
Drug: BRI-1501

Study type

Interventional

Funder types

Industry

Identifiers

NCT02759224
BR-LIC-CT-101

Details and patient eligibility

About

An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers

Enrollment

34 patients

Sex

All

Ages

19 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subject, aged 19- 50 years

Exclusion criteria

  • History of clinically significant and active disease
  • History of gastrointestinal disease
  • History of clinically significant hypersensitivity to study drug, any other drug
  • Laboratory test serum AST or ALT > 1.25 times of upper normal range serum total bilirubin > 1.5 times of upper normal range eGFR < 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive
  • Hypotension or hypertension
  • Pregnant or nursing women
  • Participation in any other study within 90 days

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Arm A (Lafutidine and Irsogladine maleate --> BRI-1501)
Other group
Description:
Subjects of Arm A take Lafutidine and Irsogladine maleate Individual tablets at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm A take a BRI-1501 tablet at 36th day
Treatment:
Drug: BRI-1501
Drug: Lafutidine
Drug: Irsogladine maleate
Arm B (BRI-1501 --> Lafutidine and Irsogladine maleate)
Other group
Description:
Subjects of Arm B take a BRI-1501 tablet at 1st day as period I. And then, after wash out for 35 days, as period II, subjects of Arm B take Lafutidine and Irsogladine maleate Individual tablets at 36th day
Treatment:
Drug: BRI-1501
Drug: Lafutidine
Drug: Irsogladine maleate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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