CKD-828 Drug Interaction Study (Telmisartan)

Healthy Male Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356017
• Other study ID #: 130HPS11C
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2011
• Last updated: September 4, 2011
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telmisartan AUC		0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr	No
Secondary	Telmisartan Cmax		0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr	No
Secondary	Telmisartan Tmax		0, 192, 192.5, 193, 193.5, 194, 195, 196, 197, 198, 200, 202, 204, 216 hr	No