Healthy Subjects Not Applicable
Conditions
Interventions
To demonstrate the bioequivalence of a generic product containing phenazopyridine (one tablet x 100 mg) as test product Uropyrine® with the original formulation of phenazopyridine (one tablet x 100 mg
Sponsors
Pacific Pharma Corporation (Korea, South)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 19 to 55 2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests 3. Informed consent signed by the subject 4. Not pregnant female subject
Exclusion criteria
Exclusion criteria: 1. Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 1 month prior to dosing 2. Use of prescription or nonprescription drugs within 10 days prior to the first dose of study medication 3. Subjects who are known or suspected not to comply with the study directives 4. Participating in a bioequivalence study or other clinical study within 3 month preceding the first dose of study medication 5. Pregnant or nursing females 6. Subject who are hypersensitive to study medication or other related compounds 7. History of sensitivity to thiazide diuretics or sulfonamides 8. Acute or Chronic renal failure (creatinine clearance < 30mL/min), anuric patient 9. Severe Hepatic failure 10. Biliary atresia, biliary cirrhosis 11. Hyponatremia, hypokalemia, hypercalcemia, hyperuricemia patient 12. Addison's disease patient 13. Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of the pharmacokinetic parameters: 1. Serum Cmax 2. AUC | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of the pharmacokinetic parameters - Serum Tmax | — |
Countries
Korea, South
Outcome results
None listed