CKD-828 Drug Interaction Study (Telmisartan)

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Collaborator: Asan Medical Center
• Treatments: Amlodipine; Telmisartan

Criteria

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

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 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