Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fasting Conditions

June 19, 2013 updated by: IPCA Laboratories Ltd.

An Open Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Balanced, Single Dose Oral Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg of Ipca Laboratories Limited, India and 'Toprol-XL®' (Metoprolol Succinate) Extended Release Tablets 200 mg of Astrazeneca LP, USA In Healthy Adult Human Subjects Under Fasting Conditions

This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in healthy adult human subjects.

Study Overview

Detailed Description

Objective of this pivotal study was to assess the bioequivalence between Test Product: Metoprolol Succinate 200 mg Ipca Laboratories Limited, India and the corresponding Reference Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 200 mg of Astrazenica LP, USA under fasting condition in healthy adult human subjects in a randomized crossover study.

The study was conducted with 48 healthy adult subjects. In each study period, a single 200 mg dose of either test or reference was administered to the subjects as per the randomization schedule in each study period with about 240 mL of water at ambient temperature in sitting position.

The duration of the clinical phase was approximately 11 days including washout period of at least 7 days between administrations of study drug in each study period.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gujarat
      • Ahmedabad, Gujarat, India, 380054
        • Cliantha Research Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 to 45 years old, both inclusive.
  2. Sex: Males and/or non-pregnant, non-lactating females.
  3. BMI: 18.5 to 24.9 weight in kg/(height in meter)2 both inclusive;
  4. Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
  5. Able to give written informed consent to participate in the study.
  6. All volunteers must be judged by the principal or co-investigator or physician as normal and healthy during a pre-study safety assessment performed within 21 days of the first dose of study medication which will include:

    • A physical examination with no clinically significant finding.
    • Results within normal limits or clinically non-significant for the tests mentioned in List of Laboratory Parameters:
    • Additional tests and/or examinations may be performed, if necessary, based on Principal Investigator discretion.
    • All results will be assessed against the laboratory normal ranges current at the time of testing and a copy of the normal ranges used will be included in the study documentation.

Exclusion Criteria:

  1. History of allergic responses to Metoprolol Succinate or other related drugs, or any of its formulation ingredients.
  2. Have significant diseases or clinically significant abnormal findings during screening, [medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) & transvaginal ultrasonography (for female volunteers)].
  3. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
  4. History or presence of bronchial asthma.
  5. Use of any hormone replacement therapy within 3 months prior to study medication dosing.
  6. A depot injection or implant of any drug within 3 months prior to administration of study medication.
  7. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
  8. History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
  9. Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period.
  10. History of difficulty with donating blood or difficulty in accessibility of veins.
  11. History of allergic response to heparin.
  12. A positive hepatitis screen (includes subtypes B & C).
  13. A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
  14. Volunteers who have donated blood (1 unit or 450 mL) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study, (≤100 mL within 30 days; ≤200 mL within 60 days; >200 mL within 90 days) prior to initial dose of study drug.
  15. History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.
  16. Intolerance to venipuncture
  17. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteer's participation in this study.
  18. Volunteers who have received a known investigational drug within five elimination half life of the administered drug prior to the initial dose of study drug or who have participated in a clinical drug study or bioequivalence study within 90 days prior to the initial dose of study drug, whichever is greater.
  19. Found positive in urine test for drugs of abuse done before check-in of period I.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 'TOPROL-XL®' ER Tablets 200 mg
'TOPROL-XL®' ER Tablets 200 mg of Astrazeneca LP, USA
1 * 200 mg tablet per day
Other Names:
  • Test Product
1 * 200 mg tablet per day
Other Names:
  • Reference Product
Experimental: Metoprolol Succinate ER Tablet 200 mg
Metoprolol Succinate ER Tablet 200 mg of Ipca Laboratories Limited, India
1 * 200 mg tablet per day
Other Names:
  • Test Product
1 * 200 mg tablet per day
Other Names:
  • Reference Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioequivalence is based on Cmax and AUC parameters.
Time Frame: 1 Month
Area Under Curve (AUC)and Cmax Sampling Hours: Pre-dose and at 1.0, 2.0, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0,11.0, 12.0, 13.0, 14.0, 16.0, 20.0, 24.0, 36.0 and 48.0 hours post dose.
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr. Manish Singhal, M.B.B.S, Cliantha Research Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 19, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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