Phase I clinical study to compare the safety and pharmacokinetics of HUG116 tablet (Tenofovir Disoproxil) with Viread® tablet (Tenofovir Disoproxil Fumarate) in healthy male volunteers
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0003771
- Lead Sponsor
- Chungnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 50
1. Healthy adult men aged 19 to 45 years of age at screening
2. Those who weigh more than 55 kg and fall within ± 20% of the calculated IBW
? Ideal Body Weight (IBW, kg) = (height (cm) - 100) × 0.9
3. Those who do not have congenital or chronic diseases and do not have medical examination results, pathological symptoms or findings
4. The person who is determined to be eligible for the test result of clinical laboratory tests such as hematology test, blood chemistry test, urine test,
5. A person who has given full explanation of the clinical trial and has agreed in writing to fully participate in the decision and to observe the instructions.
1. Person with clinically significant liver dysfunction, kidney, digestive system, respiratory system, blood / tumor system, endocrine system, urinary system, neuropsychiatry, musculoskeletal system, immune system
2. Persons with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of pharmaceuticals for clinical trials
3. Persons with hypersensitivity or clinically significant hypersensitivity reactions to the components of the clinical trial medication (including Yellow No. 5 (Sunset Yellow FCF)) or other components contained in the medicinal product
4. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
5. In the presence of a vital sign measured in a sitting position, a value that is included in any of the criteria of systolic blood pressure> 140 mmHg or <100 mmHg, diastolic blood pressure> 90 mmHg or <60 mmHg, and pulse rate = 100 times / minute
6. AST or ALT exceeds 2 times the upper limit of the reference range, or Total Bilirubin exceeds 2 times the upper limit of the reference range
7. Patients with renal impairment (Cockcroft-Gault-type creatinine clearance <50 mL / min)
8. Serum test (RPR Ab (VDRL), HBsAg, HCV Ab, anti HIV (AIDS)) Result positive
9. A person who has a history of drug abuse or has been tested positive by a screening test
10. Those who take medication for the induction and inhibition of drug metabolizing enzymes such as barbiturate drugs within 1 month before the first dosing day
11. In the case of taking any special medicines (ETC drugs) or herbal medicines within 2 weeks before the first dosing day, or taking any general medicines (OTC medicines) or vitamin preparations within 1 week, If it is determined that it may affect the test or affect the safety of the testee
12. Those who have participated in other clinical trials or bioequivalence studies within 3 months of the first administration day and administered the clinical trial drug
13. All blood donated within 2 months before the first dosing day or blood donated within 1 month, or received a blood transfusion within 1 month before the first dosing day
14. Persons who continue to drink excessively (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from discharge 24 hours before discharge
15. Over the last three months, an average of 10 smokers a day, excessive caffeine intake (eg, caffeine> 400 mg / day)
16. Anyone who is scheduled for dental treatment (extraction, correction, neurological treatment, etc.) and selective surgery (cosmetic surgery, LASIK, LASEK, etc.) during the period from signing the consent to the post-
17. A person who is found to be unsuitable for clinical trial participation due to other reasons including clinical examination results
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax of Tenofovir;AUCinf, tmax, t1/2ß, CL/F of Tenofovir
- Secondary Outcome Measures
Name Time Method Vital signs (blood pressure, pulse rate, body temperature);12 Electrocardiography (EGG);Clinical laboratory tests: hematology, blood chemistry, urinalysis;Adverse reaction: Confirm drug combination;Physical examination