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OpenTrials
Completed

NCT Number: NCT02759224

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

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

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Key information

Conditions

Gastric Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Catholic University of Korea, Seoul St.Mary's Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BRI-1501

Drug

Lafutidine

Drug

Irsogladine maleate

Drug

Primary outcomes

  1. Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate

    Time frame: 0~36 hour after medication

  2. Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate

    Time frame: 0~36 hour after medication

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 3, 2016
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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