CKD-828 Drug Interaction Study (S-amlodipine)

This study has been completed.
Sponsor:
Collaborator:
Asan Medical Center
Information provided by:
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01356043
First received: May 17, 2011
Last updated: August 29, 2011
Last verified: August 2011

May 17, 2011
August 29, 2011
May 2011
August 2011   (final data collection date for primary outcome measure)
S-amlodipine AUC [ Time Frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01356043 on ClinicalTrials.gov Archive Site
  • S-amlodipine Cmax [ Time Frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr ] [ Designated as safety issue: No ]
  • S-amlodipine Tmax [ Time Frame: 0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
CKD-828 Drug Interaction Study (S-amlodipine)
A Randomized, Open-label, Multiple Doses, Crossover Study to Evaluate the Pharmacokinetic Drug Interaction and Safety of S-amlodipine Between Free Combination of S-amlodipine and Telmisartan and S-amlodipine Monotherapy in Healthy Male Volunteers

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Male Volunteers
  • Drug: S-amlodipine 5mg,Telmisartan 80mg
    S-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)
    Other Name: Anydipine S 5mg, Micardis 80mg
  • Drug: S-amlodipine 5mg
    S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out(19 days)
    Other Name: Anydipine S 5mg
  • Experimental: Free combination of S-amlodipine and Telmisartan
    Subjects received S-amlodipine 5mg and Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days.
    Intervention: Drug: S-amlodipine 5mg,Telmisartan 80mg
  • Active Comparator: S-amlodipine monotherapy
    Subjects received S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days.
    Intervention: Drug: S-amlodipine 5mg
Noh YH, Lim HS, Kim MJ, Kim YH, Choi HY, Sung HR, Jin SJ, Lim J, Bae KS. Pharmacokinetic interaction of telmisartan with s-amlodipine: an open-label, two-period crossover study in healthy Korean male volunteers. Clin Ther. 2012 Jul;34(7):1625-35. doi: 10.1016/j.clinthera.2012.05.010. Epub 2012 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01356043
130HPS11D
No
Jin Kim/ Director, Clinical Research Department
Chong Kun Dang Pharmaceutical
Asan Medical Center
Principal Investigator: Kyun S Bae, Ph.D. Asan Medical Center
Chong Kun Dang Pharmaceutical
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP