CKD-828 Drug Interaction Study (S-amlodipine)

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: S-amlodipine 5mg; Drug: S-amlodipine 5mg,Telmisartan 80mg

• Registration Number: NCT01356043
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine monotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Between 20 aged and 50 aged in healthy males
• Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening
• 100mmHg ≤ sit SBP < 140mmHg and 60mmHg ≤ sit DBP < 90mmHg and 50 per/min ≤ Pulse rate < 95 per/min
• AST, ALT, Total bilirubin < UNL x 1.5
• Signed the informed consent from prior to the study participation

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Exclusion Criteria

• Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
• Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer) or surgery(except for Appendectomy, Hernia repair) affected by the absorption of medications
• galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
• Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of telmisartan or Amlodipine
• drug abuse, or have a history of drug abuse showed a positive for the Triage TOX drug on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, THC(cannabinoids), methadone etc.
• Subject who takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of study treatment
• unusual diet affected by the absorption, distribution, metabolism, excretion of medications
• Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
• Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
• Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days
• A heavy caffeine consumer (caffeine > 5 units/day)
• A heavy alcohol consumer (alcohol > 21 units/week, 1 unit=pure alcohol 10mL) or cannot stop drinking
• A heavy smoker (cigarette > 20 cigarettes per day)
• Positive for Hepatitis B, Hepatitis C, HIV or syphilis
• An impossible one who participates in clinical trial by investigator's decision including laboratory test result, EKG result

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
S-amlodipine monotherapy	S-amlodipine 5mg	Subjects received S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days.
Free combination of S-amlodipine and Telmisartan	S-amlodipine 5mg,Telmisartan 80mg	Subjects received S-amlodipine 5mg and Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days.

Primary Outcome Measures

Name	Time	Method
S-amlodipine AUC	0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

Secondary Outcome Measures

Name	Time	Method
S-amlodipine Cmax	0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr
S-amlodipine Tmax	0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of