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

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Viread 300mg; Drug: DA-2802 319mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02557594

DA2802_BE_I

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 2 patient groups

Viread → DA-2802

Experimental group

Description:

* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)

Treatment:

Drug: DA-2802 319mg

Drug: Viread 300mg

DA-2802 → Viread

Experimental group

Description:

* Viread 300mg(Tenofovir disoproxil fumarate) * DA-2802 319mg(Tenofovir disoproxil orotate)

Treatment:

Drug: DA-2802 319mg

Drug: Viread 300mg