CKD-828 (80/5mg) Pharmacokinetic Study
Information source: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: CKD-828 (Drug); Telmisartan (Drug); S-amlodipine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Chong Kun Dang Pharmaceutical Official(s) and/or principal investigator(s):
Young-Ran Yoon, Principal Investigator, Affiliation: Kyungpook National University Hospital Clinical Trial Center
Summary
A randomized, open-label, single-dose, four-period, two-way, crossover study,
Clinical Details
Official title: A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Secondary outcome: Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. Number of participants with adverse events
Detailed description:
A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the
pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration
telmisartan and s-amlodipine in health volunteers.
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- A healthy volunteer over 20 years old
- More than 50kg and within 20% of ideal body weight
- No any congenital or chronic diseases and medical symptom
- Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks
prior to the first IP administration
- Signed the informed consent form prior to the study participation.
Exclusion Criteria:
- History of relevant hypersensitivity against drug
- Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo,
hemato, onco, CNS etc.)
- Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin >
1. 5*ULN)
- SBP <90mmHg or SBP >150mmHg
- DBP <50mmHg or DBP >100mmHg
- Creatinine clearance <80mL/min
- A Disease(ex. inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic
disease history , gastro-intestinal surgery except for appendectomy)that may
influence on the absorption, distribution, metabolism and excretion of the drug
- The evidence of severe attack or acute disease or surgical intervention within 28
days prior to the first IP administration.
- A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular
alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes
per a day)
- Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within
7days prior to the first IP administration
- Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP
administration) that may influence on the absorption, distribution, metabolism and
excretion of the drug
Locations and Contacts
Kyungpook National University Hospital, Daegu, samdeok-dong, 2-ga 50, samdeok-dong, 2-ga 50 Jung-gu 700-721, Korea, Republic of
Additional Information
Starting date: February 2015
Last updated: July 6, 2015
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