Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Viread 300mg; Drug: DA-2802 319mg

• Registration Number: NCT02557594
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2015-10-06
• Primary Completion: 2015-11-17
• Study Completion: 2016-03-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Age between 20 to 50, healthy male subjects(at screening)
• Body weight over 55kg, BMI between 18.0 - 27.0
• Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria

• Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder)
• Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
• Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread
• Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics
• exceed 1.5 times the normal range of AST, ALT at screening test before randomization
• history of drug abuse, or a positive urine drug screen
• having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
• Participation in any other clinical trial involving investigational drugs within 3 months
• Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
• Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
• Volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge)
• Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods
• Volunteers who are not using adequate contraception methods or have a pregnancy plan
• volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study
• any condition that, in the view of the investigator, would interfere with study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Viread → DA-2802	Viread 300mg	* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)
Viread → DA-2802	DA-2802 319mg	* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)
DA-2802 → Viread	DA-2802 319mg	* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)
DA-2802 → Viread	Viread 300mg	* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)

Primary Outcome Measures

Name	Time	Method
Area Under Curve(AUC)last of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Maximum of concentration(Cmax) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose

Secondary Outcome Measures

Name	Time	Method
Terminal half-life(t1/2) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Time of maximum concentration(Tmax) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Apparent Clearance(CL/F) of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose
Area Under Curve(AUC)inf of Tenofovir	0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose

Trial Locations

Locations (1)

Clinical Trial Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of