NCT02811731

Brief Summary

The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

June 12, 2016

Last Update Submit

June 21, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • AUCt

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

    0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

  • Cmax

    A. Candesartan: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48 hr B. Amlodipine: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

    0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

Secondary Outcomes (4)

  • AUCinf

    0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

  • tmax

    0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

  • t1/2β

    0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

  • CL/F

    0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hr

Study Arms (2)

Candesartan and Amlodipine

EXPERIMENTAL

Candesartan 16mg and Amlodipine 5mg, PO, 1days or 22days

Drug: Candesartan 16mg and Amlodipine 5mg

CKD-330

EXPERIMENTAL

CKD-330 16/5mg - B, PO, 1days or 22days

Drug: CKD-330 16/5mg - B

Interventions

CKD-330 16/5mg - BDRUG
CKD-330
Candesartan 16mg and Amlodipine 5mgDRUG
Candesartan and Amlodipine

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteer in the age between 19 and 45 years old.
  • Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
  • Subjects without a hereditary problems and chronic disease.
  • Subjects whose clinical laboratory test values are inside the accepted normal range.
  • Understand the requirements of the study and voluntarily consent to participate in the study.

You may not qualify if:

  • Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
  • History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
  • History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
  • Subjects with galactose intolerance.
  • SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 BPM.
  • AST or ALT \> 2\*ULN, total bilirubin \> 2\*ULN
  • Serum Creatinine \> ULN
  • Previous history or present of drug abuse.
  • Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
  • Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
  • Subjects treated IP within 2 months prior to the first dosing.
  • Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
  • Alcohol \> 21 units/week or cannot stop drinking.
  • Cigarette \> 10 cigarettes/day.
  • Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

candesartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jang Hee Hong

    Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2016

First Posted

June 23, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

June 23, 2016

Record last verified: 2016-06