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Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

NCT01004614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-01-28

Study results available
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Summary

This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.

Conditions

  • Healthy

Interventions

DRUG

Amlodipine

3rd OD 5 mg tablet single oral dose administered with water

DRUG

Amlodipine

2nd OD 5 mg tablet single oral dose administered with water

DRUG

Amlodipine

3rd OD 5 mg tablet single oral dose administered without water

DRUG

Amlodipine

2nd OD 5 mg tablet single oral dose administered without water

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Japan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01004614 on ClinicalTrials.gov