Bioequivalence of torasemide 10 mg in Korean subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000794

Enrollment

Registered

2013-07-17

Start date

2004-05-28

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Test drug: Boryung Pharm. Co., Ltd., "Boryung Torasemide tablet 10 mg (torasemide 10 mg)", 2 tablets, once per oral Reference drug: Roche Korea Co., Ltd., "Torem tablet 10 mg (torasemide 10 mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects between the ages of 19 and 55 years 2. No History of congenital or chronic disease 3. No clinically relevant abnormalities identified by laboratory test, including hematology, blood chemistry, and urinalysis 4. Female subject known to be negative for pregnant test

Exclusion criteria

Exclusion criteria: 1. Use of any drugs (barbitals, alcohol) known to significantly induce or inhibit drug-metabolizing enzymes within 1 month prior to dosing 2. Received any drugs within 10 days before the study 3. Inappropriate subject for entry into this study in the judgement of the investigator 4. Participating in a bioequivalence study or other clinical study within 3 month preceding the first dose of study medication

Design outcomes

Primary

Measure	Time frame
AUC(area under the serum concentration-time curve);Cmax(maximum serum drug concentration)	—

Secondary

Measure	Time frame
The 90% confidence intervals using logarithmically transformed AUC and Cmax were within the acceptance range of log0.80 to log1.25.	—

Countries

Korea, Republic of

Contacts

Public ContactYong-Bok Lee

Chonnam National University

Outcome results