CKD-828 Drug Interaction Study (S-amlodipine)

NCT ID: NCT01356043

Last Updated: 2011-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

S-amlodipine 5mg,Telmisartan 80mg

Intervention Type: DRUG

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

S-amlodipine monotherapy

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

Group Type: ACTIVE_COMPARATOR

S-amlodipine 5mg

Intervention Type: DRUG

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

Interventions

S-amlodipine 5mg,Telmisartan 80mg

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

Intervention Type: DRUG

S-amlodipine 5mg

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

Intervention Type: DRUG

Other Intervention Names

Anydipine S 5mg, Micardis 80mg; Anydipine S 5mg

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: collaborator

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Clinical Research Department

Principal Investigators

Kyun S Bae, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 22721873 (View on PubMed)

Other Identifiers

130HPS11D

Identifier Type: -

Identifier Source: org_study_id