CKD-828 Drug Interaction Study (Telmisartan)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01356017

Enrollment

Registered

2011-05-19

Start date

2011-06-30

Completion date

2011-09-30

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Volunteers

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.

Interventions

DRUGTelmisartan 80mg, S-amlodipine 5mg

Telmisartan 80mg and S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out (19 days)

DRUGTelmisartan 80mg

Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026