CKD-828 Drug Interaction Study (S-amlodipine)

NCT01356043 | Completed Phase 1

• 1 other identifier: 130HPS11D
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (1)

• S-amlodipine AUC

  0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

Secondary Outcomes (2)

• S-amlodipine Cmax

  0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

• S-amlodipine Tmax

  0, 192, 193, 194, 195, 196, 197, 198, 199, 200, 202, 204, 206, 216 hr

Study Arms (2)

Free combination of S-amlodipine and Telmisartan

EXPERIMENTAL

Subjects received S-amlodipine 5mg and Telmisartan 80mg once a day for 9 days. And subjects doesn't take any medications for 19 days.

Drug: S-amlodipine 5mg,Telmisartan 80mg

S-amlodipine monotherapy

ACTIVE COMPARATOR

Subjects received S-amlodipine 5mg once a day for 9 days. And subjects doesn't take any medications for 19 days.

Drug: S-amlodipine 5mg

Interventions

S-amlodipine 5mg,Telmisartan 80mg DRUG

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

Also known as: Anydipine S 5mg, Micardis 80mg

Free combination of S-amlodipine and Telmisartan

S-amlodipine 5mg DRUG

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

Also known as: Anydipine S 5mg

S-amlodipine monotherapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20 aged and 50 aged in healthy males
• Weight more than 55kg, BMI 19kg/m2-26kg/m2 at the period of screening
• mmHg ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead
• Asan Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22721873 DERIVED

MeSH Terms

Interventions

levamlodipine; Telmisartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kyun S Bae, Ph.D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: May 19, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

KR (1)