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Safety and Pharmacokinetics Study of Amlodipine 10mg and Candesartan 32mg

S

Shin Poong Pharmaceutical

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: candesartan cilexetil 32mg, amlodipine 10mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01926652
SP-AC-001

Details and patient eligibility

About

Clinical trial to evaluate the pharmacokinetic interactions and safety between single dose of amlodipine 10mg and candesartan 32mg and the combination dose amlodipine 10mg with candesartan 32mg in healthy male volunteers.

Enrollment

34 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Male volunteers in the age between 20 and 55 years old(inclusive).
  2. Body weight >= 55kg and Body mass index (BMI) in the range of calculated IBW ±20%.
  3. Subjects without a hereditary problems or chronic desease.
  4. Subjects whose clinical laboratory test values are inside the accepted normal range.
  5. Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion criteria

  1. Subjects with a history of gastrointestinal diseases which might significantly change ADME of medicines.
  2. Systolic blood pressure range ≥150 mmHg or ≤ 100 mmHg or diastolic blood pressure range ≥ 95 mmHg or ≤ 60 mmHg.
  3. Subject with symptoms of acute disease within 14days prior to study medication dosing.
  4. Subjects with a history of clinically significant allergies of amlodipin or candesartan or CCB or other medicine (ex. aspirin or antibiotics).
  5. Subjects with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
  6. Serum creatinine > 1.2mg/dL.
  7. smoking > 10 cigarettes/day.
  8. alcohol > 210g/week.
  9. Positive test results for drug test in urin or subject with history of substance abuse.
  10. Participation in any clinical investigation within 2 months prior to study medication dosing.
  11. Subjects with whole blood donation within 2 months, component blood donation within 1 month and blood transfusion within 1 month prior to study medication dosing.
  12. Subjects considered as unsuitable based on medical judgement by investigators.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

34 participants in 2 patient groups

candesartan
Experimental group
Description:
Single administration : candesartan cilexetil 32mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd
Treatment:
Drug: candesartan cilexetil 32mg, amlodipine 10mg
amlodipine
Experimental group
Description:
Single administration : amlodipine 10mg, qd. Combination administration : candesartan cilexetil 32mg and amlodipine 10mg, qd
Treatment:
Drug: candesartan cilexetil 32mg, amlodipine 10mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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