An Open-Label, Two-Period, One Sequence, Drug-Drug Interaction Study to Investigate the Effect of Clarithromycin and Rifampicin on the Pharmacokinetic Profiles of DA-1229 in Healthy Adults
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007689
- Lead Sponsor
- Dong-A ST
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 24
1) Healthy male volunteers with age = 20 and = 55 years at screening
2) BMI = 18.5 and < 25.0 kg/m^2; where BMI (kg/m^2) = body weight (kg) / {height (m)}^2
3) Body weight = 55 kg
4) Fasting plasma glucose (FPG) = 70 mg/dL and < 100 mg/dL
5) Determined to be eligible for the study based on hematology, blood chemistry, immunology/serology, urinalysis as well as ECG which are selected and performed by the investigator with considering the properties of IPs as follows: (including non clinically significant abnormal)
- Hematology: WBC with differential count, RBC, hemoglobin, hematocrit, platelet, and PT (INR)/aPTT
- Blood chemistry: calcium, inorganic phosphate, fasting glucose, BUN, creatinine, cholesterol, total protein, albumin, total bilirubin, alkaline phosphatase, AST, ALT, gamma-GT, LDH, TG, K, Na, Cl, uric acid, and CPK
- Immunology/serology: HBsAg, anti-HCV Ab, and anti-HIV Ag/Ab
- Urinalysis: specific gravity, pH, protein, glucose, ketone, RBC, urobilinogen, bilirubin, nitrite, WBC, color, turbidity, and microscopy urine drug screening: amphetamine, barbiturates, morphine, benzodiazepines, and cocaine
6) A Subject whose partner is a woman of child-bearing potential should agree to use an appropriate method of birth control (e.g., condom) and not to donate sperm during the study and at least 28 days after the last IP administration; of note, the subject or his partner is sterile, the birth control method mentioned above is not required.
7) Consent to participate in the study voluntarily and comply with the precautions for the study by his signature after being fully informed and understanding of all aspects pertaining to the study.
1) Known hypersensitivity to the investigational products or their excipients.
2) History of glucose intolerance or diabetes
3) History or presence of clinically significant hepatobiliary, renal, neurologic, psychiatric, pulmonary, endocrine, hematological, neoplastic, cardiovascular or immunologic disease
4) History of gastrointestinal disease (such as Crohn's disease or ulcer) or gastrointestinal surgery (except for appendectomy and herniotomy) possibly affecting drug absorption.
5) SBP < 90 mmHg or >150 mmHg, or DBP < 50 mmHg or > 100 mmHg when measured at sitting position after rest for at least 5 minutes.
6) Screening laboratory results as follows:total bilirubin >1.5 times the upper limit of normal values, AST (SGOT) or ALT (SGPT) > 1.25 times the upper limit of normal values, eGFR calculated by MDRD equation = 60 mL/min/1.73m^2 where eGFR (estimated glomerular filtration rate)(mL/min/1.73m^2) = 175 x [serum creatinin (mg/dL)]-1.154 x [age (year)]-0.203 (x 0.742, if female)
7) QTc (as QTcB; corrected by Bazett’s formula) > 450 msec or clinically significant abnormalities in ECG which may effect on the safety of subjects or the interpretation of study results.
8) History of significant drug abuse within 1 year prior to screening or a positive result in urine drug screening for drug abuse.
9) Administration of a drug, St. John’s wort or relevant preparation which may effect on the metabolism of the investigational products within 30 days prior to the first IP administration.
10) Applying or taking the following drugs other than oral contraceptives or topical agents of which significant amount is not absorbed systemically within certain period below:
prescription drugs within 14 days prior to the first IP administration; OTCs including herbal medicines or vitamin supplements within 7 days prior to the first IP administration; or depot formulations or other drugs for implantation except for contraceptives within 30 days prior to the first IP administration.
11) History of alcohol dependence within 1 year prior to screening, persistent consumption of alcohol (>210 units of alcohol per week) within 6 months prior to screening, or inability to abstain from drinking from 2 days prior to the first IP administration through the day of final blood sampling for pharmacokinetics.
12) Persistent consumption of caffeine-containing products (e.g., >5 cups of coffee, >1,250 mL of tea, or >1,250 mL of cola per day) or unable to abstain from taking caffeine-containing products from 2 days prior to the first study drug administration through the day of final blood sampling for harmacokinetics.
13) Smokers of more than 10 cigarettes/day persistently or unable to abstain from smoking from 2 days prior to the first IP administration through the day of final blood sampling for pharmacokinetics.
14) Intake of grapefruit-containing products within 7 days prior to the first IP administration.
15) Participation in any other clinical trial and administration of any investigational product within 60 days prior to the first IP administration except for biologics for which within 3 months and the duration can be extended considering the elimination half-life of the products.
16) Donation of a unit of whole blood within 60 days or blood components within 30 days prior to the first study drug administration.
17) Any other conditions which in the opinion of the investigator would have made the subject unsuitable for the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUClast and Cmax of DA-1229
- Secondary Outcome Measures
Name Time Method AUClast and Cmax of M7 and M8, AUCinf, Tmax, t1/2, and Vd of DA-1229, M7, and M8 , AUCt,ss, and Cmin,ss of clarithromycin (only for Group A)