Microdose drug-drug interaction study to evaluate the effect of rifampin on the pharmacokinetics of omeprazole

An Open-Label, Multiple-Dose, One-Sequence Crossover Study to Crossover Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Omeprazole after Oral Administration of Microdosing and Full-Dosing of Omeprazole in Healthy Male Volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002203

Enrollment

Registered

2017-01-31

Start date

2016-08-16

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 : Open-Label, One-sequence crossover study Day 0: omeprazole 100 ug Day 1: omeprazole 20 mg Day 2~7: rifampin 150 mg once a day Day 8: omeprazole 100 ug + rifampin 150 mg Day 9: omeprazole 20 m

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male Korean subject age 19 to 45 at the screening visit 2. Subject who is over 55kg and as a result of calculated Ideal Body Weight, subject who is within the range of ±20% 3. After understanding to hear detaily description of the clinical trial, subject who decided voluntarily to participate in clinical trail and agreed to observe notice

Exclusion criteria

Exclusion criteria: 1. history or clinical manifestation of clinically significant cardiovascular, respiratory, renal, endocrine, hematologic, digestive, central nervous, psychiatric disorder or malignant tumor; 2. history of gastrointestinal tract disease (Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that may affect the absorption of fluconazole and omeprazole 3. significant hypersensitive or clinically significant hypersensitivity reactions to any drug compound or other azole medicines or additives 4. determined as not appropriate for study participant during healthy examination (medical history, physical exam, lab test, vital sign) at screening 5. abnormalities in laboratory test - AST or ALT > 1.5x upper limit of normal [ULN] - Total bilirubin > 1.5x ULN - CPK > 1.5x ULN 6. After resting for more than 5 minutes, systolic blood pressure =140 mmHg or =90 mmHg, diastolic blood pressure =90 mmHg or =60 mmHg in 7. history of drugs abuse 8. consumption of excessive caffeine, alcohol, and cigarette (caffeine: 5 cups/day, alcohol: 210g/week, cigarette: >10/day) 9. use of other clinical trial's investigational drug within 90 days prior to investigational study drug administration 10. use of drug metabolizing enzyme inducers or inhibitors such as barbiturates within 30 days prior to investigational study drug administration 11. donation of blood from 60 days or plasma from 30 days prior to investigational study drug administration 12. consumption of grapefruit-containing foods and beverages within 7 days prior to investigational study drug administration 13. use of any prescription medicines or herbal medicines within 14 days prior to investigational study drug administration or over-the-counter or vitamin preparations within 7 days before prior to investigational study drug administration 14. ineligible for participation in clinical trials due to other reasons

Design outcomes

Primary

Measure	Time frame
Cmax, AUClast for omeprazole	—

Secondary

Measure	Time frame
AUCinf, tmax, t1/2 for omeprazole	—

Countries

Korea, Republic of

Contacts

Public ContactWan-Su Park

The Catholic University of Korea, Seoul St. Mary's Hospital

walsu1109@gmail.com+82-2-2258-7327

Outcome results