A Randomized, Open, 2-way cross-over, Single dose study to Evaluate and Compare Safety and Pharmacokinetics of the HIP1302 and HGP1406 in Healthy Korean Male Volunteers
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0001635
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 38
1.Healthy male volunteer, age 19~50 years
2.Weight =55kg and =90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3.Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4.Subjects who judged ineligible by the investigator.
1.Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in liver, kidney, nervous system, respiratory system, endocrine system,blood dyscracia, neoplasm,cardiovascular system,genitourinary system or psychiatric system.
2.Presence of medical history or a concurrent disease that may interfere with PK/PD evaluation of drugs including clinically significant disorders in Gastrointestinal tract
3.Subject who has genetic problems (i.e galactose intolerance, Lapp lactose deficiency and glucose-galactose malabsorption etc)
4.History of relevant drug allergies(i.e Tenofovir, Aspirin, Antibiotics etc) or clinically significant hypersesnsitivity reaction.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast of Tenofovir;Cmax of Tenofovir
- Secondary Outcome Measures
Name Time Method Tmax of Tenofovir;t1/2 of Tenofovir;CL/F of Tenofovir;AUCinf of Tenofovir;MRT of Tenofovir;Vd/F of Tenofovir