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

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

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

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer
• Intervention / Treatment: Drug: Lafutidine; Drug: Irsogladine maleate

Detailed Description

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 before 28days of first administration. Subjects administrate Lafutidine bid during period I. After wash-out period, administrate Irsogladine maleate qd during Period II. After than, coadministration Lafutidine bid and Irsogladine maleate qd.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy subjects between the ages of 19 and 50 at the screening

2. 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

3. 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.
4. 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.)
5. Subjects who understand the clinical study completely, agree to participate and sign written consent form for conduct precautions

Exclusion Criteria:

1. 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
2. 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)
3. Subjects having a history of hypersensitivity to additional ingredient or clinically significant hypersensitivity to lafutidine and Irsogladine or any other drug.
4. Subjects who judged for inappropriate to physical examination. ( Disease history, physical examine, vital sign, EKG examine, laboratory examine and so on ).
5. Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption and any other hereditary disorder.
6. 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
7. Subjects having a history of drug abuse or positive drug abuse urinalysis testing at screening.
8. Subjects who is pregnancy or feed breast milk.
9. 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
10. Subjects who has drunken beverages caffeine-containing or alcohol or smoking during prohibition period
11. Subjects who has judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm; 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; Lafutidine 10mg, 1 tablet, bid; Other Names: STOGAR; Drug: Irsogladine maleate; Irsogladine maleate 2mg, 2 tablet, qd; Other Names: STOWON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: The Catholic University of Korea
• Investigators: Principal Investigator: Seoung-hun Han, Professor, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Peptic Ulcer; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Anticarcinogenic Agents; Radiation-Protective Agents; Histamine H2 Antagonists; Lafutidine; Irsogladine
• Other Study ID Numbers: BR-LAF-CT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No