Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

NCT01004614 | Completed Phase 1 Results

• 1 other identifier: A0531088
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-Time Curve From Zero Time Until the Last Sampling Time (AUCt)

  Area under the concentration-time curve from zero time until the last sampling time

  prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

• Maximum Observed Plasma Concentration (Cmax)

  prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Secondary Outcomes (5)

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast), Area Under the Plasma Concentration-Time Curve to Infinity (AUCinf)

  prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

• Apparent Terminal Elimination Phase Rate Constant (Kel)

  prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

• Apparent Terminal Elimination Half-Life (T-half)

  prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

• Mean Residence Time (MRT)

  prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  prior to dosing, 2, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120 and 144 hours post dose

Study Arms (2)

Cohort 1

EXPERIMENTAL

24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water.

Drug: Amlodipine

Cohort 2

ACTIVE COMPARATOR

24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water

Drug: Amlodipine

Interventions

Amlodipine DRUG

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

Cohort 1

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy;
• Body Mass Index (BMI) of 18 to 28 kg/m2;
• total body weight within the range of 50 to 100 kg

You may not qualify if:

• History of regular alcohol consumption exceeding 14 drinks/week
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day

Sponsors & Collaborators

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

Study Sites (1)

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: October 29, 2009
• First Posted: October 30, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 28, 2021
• Results First Posted: January 4, 2012

Record last verified: 2021-01

Locations

JP (1)