CKD-828 Drug Interaction Study (Telmisartan)

Phase 1

Completed

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

• Registration Number: NCT01356017
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Study Start: 2011-06
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-04
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Telmisartan AUC	0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr

Secondary Outcome Measures

Name	Time	Method
Telmisartan Cmax	0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr
Telmisartan Tmax	0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr

Trial Locations

Locations (1)

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