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

NCT01177293 | Completed Phase 1 Results

• 2 other identifiers: A0531096052-10
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

biological availability; bioavailability; amlodipine; orally disintegrating tablet; ODT; tablets

Outcome Measures

Primary Outcomes (3)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

  AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

• Maximum Observed Plasma Concentration (Cmax)

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Secondary Outcomes (2)

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

• Plasma Decay Half-life (t1/2)

  0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 and 168 hours post dose

Study Arms (2)

treatment A - reference w/ water

ACTIVE COMPARATOR

Drug: Amlodipine - reference

Treatment B - ODT (test) w/o water

EXPERIMENTAL

Drug: Amlodipine ODT - test

Interventions

Amlodipine - reference DRUG

Amlodipine capsule, 10 mg, single dose, with water

treatment A - reference w/ water

Amlodipine ODT - test DRUG

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

Treatment B - ODT (test) w/o water

Eligibility Criteria

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

You may qualify if:

• Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight \>50 kg (110 lbs).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• A positive urine drug screen.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead
• Aurobindo Pharma Ltd: collaborator
• Trident Life Sciences Ltd.: collaborator

Study Sites (1)

Pfizer Investigational Site

Hydrabad, Andhra Pradesh, 500 050, India

Location

Related Links

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

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: August 6, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 28, 2021
• Results First Posted: August 30, 2011

Record last verified: 2021-01

Locations

IN (1)