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DP-R212 Pharmacokinetic Study

A

Alvogen

Status and phase

Unknown
Phase 1

Conditions

Hypertension
Hyperlipidemias

Treatments

Drug: Rosuvastatin
Drug: Amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02789475
DP-CTR-212-I-01

Details and patient eligibility

About

An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.

Enrollment

38 estimated patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI 18-29
  • signed the informed consent form prior to the study participation

Exclusion criteria

  • Clinically significant disease
  • Previously donate whole blood within 60 days or component blood within 14 days
  • Clinically significant allergic disease
  • Taken IP in other trial within 90 days
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

38 participants in 2 patient groups

amplodipine group
Experimental group
Description:
Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days
Treatment:
Drug: Rosuvastatin
Drug: Amlodipine
rosuvastatin group
Experimental group
Description:
Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days
Treatment:
Drug: Rosuvastatin
Drug: Amlodipine

Trial contacts and locations

1

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Central trial contact

Chul woo Kim, Ph.D.

Data sourced from clinicaltrials.gov

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