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Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

NCT01177293 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-01-28

Study results available
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Summary

This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate capsule.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Amlodipine - reference

Amlodipine capsule, 10 mg, single dose, with water

DRUG

Amlodipine ODT - test

Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water

Sponsors & Collaborators

  • Aurobindo Pharma Ltd

    collaborator INDUSTRY

  • Trident Life Sciences Ltd.

    collaborator INDUSTRY

  • 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
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • India

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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 NCT01177293 on ClinicalTrials.gov