A Randomized, Open-label, Single-dose, Four-sequence, Four -period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas

A Randomized, Open-label, Single-dose, Four-sequence, Four -period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas in Healthy Male Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001363

Enrollment

Registered

2015-01-28

Start date

2013-08-23

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 : GL2702 GLARS-NF1 Tablet /day (Tamsulosin hydrochloride 0.4 mg, once a day, after meal) for one day, four period Omix Ocas® Tablet /day (Tamsulosin hydrochloride 0.4 mg, once a day, after meal

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. 20~45 years old, Healthy Adult Male Subject 2. Body Weight = 50kg and Ideal Body Weight = ±20% 3. Do not have any disease or symptoms which is clinically significant 4. Acceptable physical examination and clinical examination, during screening 5. Provision of signed written informed consent confirmed IRB

Exclusion criteria

Exclusion criteria: 1. A subject with a history of tamslosin hypersensitivity reaction or clinically significant hypersensitivity reaction 2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease 3. A subject with a history of gastrointestinal disease(crohn's disease, Ulcer) or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug 4. Unacceptable physical examination and clinical examination, during screening within 28 days prior to the participation in clinical trials 5. someone who has a result - ALT or AST > 1.25 times (Upper Normal Range) - Total Bilirubin > 1.5 times (Upper Normal Range) 6. Systolic BP >160 mmHg or 100 mmHg or < 50 mmHg 7. someone who has a history of drug abuse or misuse - alcohol abuse is consumption exceeding 21 units/week 8. someone who hsa taken a Investigator Product from other trial within 3 months before Investigator Product first medication 9. Investigator Product first dose before significant induction or that person taking drugs known to inhibit drug-metabolizing enzymes within 1 month 10. someone who has taken other Ethical drugs or herbal medicine within 2 weeks, over the counter drugs or vitamins medicine within 1 week 11. someone who has taken abnormal meals like which can affect to Absorption, Distribution, Metabolism , Excretion 12. Blood donation during 2 months or apheresis during 1 month before the study 13. galactose intolerance, Lapp lactose deficiency someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 14. Use of tobacco in excess of the equivalent of 10 cigarettes per day 15. someone who has taken positive result of HBsAg, HCV Ab, HIV Ab 16. Judged to be inappropriate for the study by the investigator after reviewing other reasons

Design outcomes

Primary

Measure	Time frame
Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® Cmax, AUClast	—

Secondary

Measure	Time frame
Tmax of Tamsulosin; t1/2 of Tamsulosin;Vz/F of Tamsulosin;CL/F of Tamsulosin	—

Countries

Korea, Republic of

Contacts

Public ContactKim G

Chonbuk National University Hospital

mgkim@jbctc.org+82-63-250-1487

Outcome results