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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01356043
Other study ID # 130HPS11D
Secondary ID
Status Completed
Phase Phase 1
First received May 17, 2011
Last updated August 29, 2011
Start date May 2011
Est. completion date August 2011

Study information

Verified date August 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 S-amlodipine between free combination of S-amlodipine and Telmisartan and S-amlodipine monotherapy.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2011
Est. primary completion date August 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 who 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


Intervention

Drug:
S-amlodipine 5mg,Telmisartan 80mg
S-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)
S-amlodipine 5mg
S-amlodipine 5mg, 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 S-amlodipine AUC 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr No
Secondary S-amlodipine Cmax 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr No
Secondary S-amlodipine Tmax 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr No
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