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NCT02759224 Clinical Trial

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

Gastric Ulcer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02759224
Other study ID # BR-LIC-CT-101
Secondary ID
Status Completed
Phase Phase 1
First received April 21, 2016
Last updated February 6, 2017
Start date April 15, 2016
Est. completion date December 29, 2016

Study information
Verified date February 2017
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date December 29, 2016
Est. primary completion date July 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• BRI-1501

• Lafutidine

• Irsogladine maleate

Locations
Country Name City State
Korea, Republic of The Catholic University of Korea, Seoul St.Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate 0~36 hour after medication
Primary Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate 0~36 hour after medication
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