CKD-828 Drug Interaction Study (Telmisartan)

Condition(s) targeted: Healthy Male Volunteers

Intervention: Telmisartan 80mg, S-amlodipine 5mg (Drug); Telmisartan 80mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Chong Kun Dang Pharmaceutical

Official(s) and/or principal investigator(s):
Kyun S Bae, Ph.D., Principal Investigator, Affiliation: Asan Medical Center

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.

Official title: A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety of Telmisartan Between Free Combination of Telmisartan and S-amlodipine and Telmisartan Monotherapy in Healthy Male Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Telmisartan AUC

Secondary outcome:

Telmisartan Cmax

Telmisartan Tmax

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

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

Asan Medical Center, Seoul, Korea, Republic of

Starting date: June 2011
Last updated: September 4, 2011