The Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers

NCT02581696 | Completed Phase 1

• 1 other identifier: BR-LAF-CT-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, multiple-dose, single-arm, phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers

Conditions

Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve of Lafutidine and Irsogladine maleate

  Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)

Secondary Outcomes (1)

• Peak Plasma Concentration of Lafutidine and Irsogladine

  Sampling time 1, 19, 21days before drug administration, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hr after drug administration. (total 24times)

Study Arms (1)

Single arm

OTHER

This is a follow-up study of BR-LAF-CT-101, a phase 1 study to evaluate the drug-drug interaction and safety of Lafutidine and Irsogladine maleate in healthy adult volunteers. Subjects judged to be appropriate to this study by screening.

Drug: Lafutidine; Drug: Irsogladine maleate

Interventions

Lafutidine DRUG

Lafutidine 10mg, 1 tablet, bid

Also known as: STOGAR

Single arm

Irsogladine maleate DRUG

Irsogladine maleate 2mg, 2 tablet, qd

Also known as: STOWON

Single arm

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects between the ages of 19 and 50 at the screening
• Male subjects whose weight is greater than 55kg Female subjects whose weight is greater than 50kg and within ±20% range of ideal body weight.
• Ideal body weight(kg) = (Height(cm) - 100) \* 0.9
• For female subjects must show negative for urine pregnancy test and also must meet one of the below listed criteria:
• A menopausal woman (Menstruation should stop at least 2 years ago)
• Take sterilization operation (Hysterectomy, Ovariotomy, Tubal ligation, any other operation)
• Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subject.
• Before 3 months of the screening and 1month after the end of drug administration, subjects must meet contraception requirements.
• For avoiding the drug-drug interaction, subjects must not use any contraceptive drugs and must choose abstinence or use physical block.
• A sexually active male subjects must use and accepted method of contraception during the course of the clinical study and must not donate sperms until a month after finishing drug administration. (If male subjects oneself or female partner is sterility, that does not apply.)
• Subjects who understand the clinical study completely, agree to participate and sign written consent form for conduct precautions

You may not qualify if:

• Subjects having liver system disorders, kidney disorders, digestive system disorders, cardiovascular disorders, respiratory disorders, endocrine disorders, neurological disorder or hematological disorders, psychiatric disorders, or a history of malignancy, disorders
• Subjects having a history of gastrointestinal system disorders influencing drug absorption(i.e, Crohn's disease, ulcer) or surgery (except simple typhlectomy or hernia repair surgery)
• Subjects having a history of hypersensitivity to additional ingredient or clinically significant hypersensitivity to lafutidine and Irsogladine or any other drug.
• Subjects who judged for inappropriate to physical examination. ( Disease history, physical examine, vital sign, EKG examine, laboratory examine and so on ).
• Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption and any other hereditary disorder.
• Subjects who is sitting after 5minutes break, having Systolic blood pressure ≥ 140 mmHg and Diastolic blood pressure ≤ 90 mmHg, or Systolic blood pressure ≥ 90 mmHg and Diastolic blood pressure ≤ 60 mmHg on vital sign
• Subjects having a history of drug abuse or positive drug abuse urinalysis testing at screening.
• Subjects who is pregnancy or feed breast milk.
• Subjects who has participated in another clinical study before study drug administration Subjects having blood donation within two months or component blood donation within one month before study drug administration
• Subjects who has drunken beverages caffeine-containing or alcohol or smoking during prohibition period
• Subjects who has judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• The Catholic University of Korea: collaborator

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Peptic Ulcer

Interventions

lafutidine; irsogladine

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Seoung-hun Han, Professor

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 21, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 6, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)