the Pharmacokinetic Profiles of Losartan With DW1029M (PLD)

A Randomized, Open-label, Multiple-dose, Crossover Phase I Clinical Study to Evaluate DW1029M Influence the Pharmacokinetic Profiles of Losartan After Oral Administration in Healthy Male Volunteer

Phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Losartan after oral administration in healthy male volunteer

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Losartan 50mg; Drug: DW1029M 1200mg and Losartan 50mg

Detailed Description

A Randomized, open-label, multiple-dose, crossover phase I clinical study to evaluate DW1029M influence the pharmacokinetic profiles of Losartan after oral administration in healthy male volunteer

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabukdo
    • Jeonju, Jeollabukdo, Korea, Republic of, 561-712
      • Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• A healthy adult within the range of 19 to 55 years old at the time of screening
• Body Mass Index(BMI)=17.5~30.5kg/m2, one with weight of more than 55kg (BMI= kg/(m)2)
• Congenital or chronic diseases within the last three years, there is no medical examination results of popular characters with no psychotic symptoms or findings
• Doctor checks conducted hematology, blood chemistry, urinalysis and laboratory tests, including an electrocardiogram(EKG) performed during screening tests such as a suitable test subjects who judged
• The purpose of the test participants prior to testing, information, and to hear about the free will fully explain to participate in this study, according to the -Institutional Review Board(IRB)-approved consent form signed by the parties in writing

Exclusion Criteria:

• one with clinically significant blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic disease (but ,except for untreated seasonal allergies of asymptomatic at the time of administration) with medical history or evidence
• one with gastrointestinal disease(Such as esophageal stricture or achalasia of the esophagus disease, Crohn disease) to affect drug absorption or surgery(but, excluding simple appendectomy or hernia surgery) with medical history
• Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 times the upper limit of the normal range
• Within 6 months, 210 g / week of alcohol in excess of a history of regular characters (beer (5%) 1 cup (250 mL) = 10 g, soju(20%) 1 cup (50 mL) = 8 g, Wine (12%) 1 cup (125 mL) = 12 g)
• Take part in other clinical trials within two months
• Systolic Blood Pressure(SBP) ≥ 140 mmHg or Diastolic Blood Pressure (DBP) ≥ 90 mmHg
• The great history of alcohol or drug abuse within 1 year
• Taking medication of drug-metabolizing enzymes that are known to significantly induce or inhibit within 30 days
• More than 20 cigarettes a day smoker
• Taking medication of a prescription drug or nonprescription within 10 days,
• Within two months the whole blood donation have, within one month of the apheresis donation have
• Participate in clinical trials to test drug administration and may be at increased risk due to interpretation of test results, or may interfere with severe supply / chronic medical or mental condition or abnormal laboratory test values in character
• Patient with hypersensitivity to investigational products or ingredients
• Patients with hereditary angioedema or angioedema
• Patients with aldosteronism
• galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Aliskiren-containing medicine (Glomerular Filtration Rate<60mL/min/1.73㎡)
• Described lifestyle in this protocol can comply with or can not
• One with other investigator judge to unsuitable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Group; 1st oral administration of Losartan 50mg and 2nd oral administration of Losartan 50mg and DW1029M 1200mg	Drug: Losartan 50mg; Losartan 50mg once daily for 7 days; Other Names: Cozaar tablet 50mg; Drug: DW1029M 1200mg and Losartan 50mg; Losartan 50mg 1 Tablet once daily and DW1029M 300mg 2 Tablets b.i.d. for 7days; Other Names: Concomitant of DW1029M 1200mg and Losartan 50mg
Experimental: B Group; 1st oral administration of DW1029M 1200mg and Losartan 50mg and 2nd oral administration of Losartan 50mg	Drug: Losartan 50mg; Losartan 50mg once daily for 7 days; Other Names: Cozaar tablet 50mg; Drug: DW1029M 1200mg and Losartan 50mg; Losartan 50mg 1 Tablet once daily and DW1029M 300mg 2 Tablets b.i.d. for 7days; Other Names: Concomitant of DW1029M 1200mg and Losartan 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax and AUC	Maximum of Concentration(Cmax), Area Under Plasma Concentration-Time Curve(AUC)	1st day and 15th day, 5th day and 19th day, 6th day and 20th day : Predose(0,morning), 7th day and 21st day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Profile of Plasma	Maximum drug concentration time(Tmax), Half-time(t1/2), Apparent renal clearance(CL/F), Apparent volume of distribution(Vd/F), Fluctuation[(Css,max-Css,min)/Css,av], Swing[(Css,max-Css,min)/Css,min]	1st day and 15th day, 5th day and 19th day, 6th day and 20th day : Predose(0,morning), 7th day and 21st day : Predose(0), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hour

Collaborators and Investigators

• Sponsor: Dong Wha Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Mingul Kim, M.D, Chounbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): June 29, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: healthy
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Losartan
• Other Study ID Numbers: DW1029M-I-5