Completed

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 Fed Conditions

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What is being tested

Metoprolol Succinate ER Tablet 200 mg

+ 'TOPROL-XL®' ER Tablets 200 mg

Drug
Who is being recruted

Hypolipoproteinemias+8

+ Lecithin Cholesterol Acyltransferase Deficiency

+ Lipid Metabolism, Inborn Errors

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorIPCA Laboratories Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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 fed 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.

Official TitleAn 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 Fed Conditions
NCT01884909
Principal SponsorIPCA Laboratories Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HypolipoproteinemiasLecithin Cholesterol Acyltransferase DeficiencyLipid Metabolism, Inborn ErrorsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesGenetic Diseases, InbornDyslipidemiasLipid Metabolism DisordersHypoalphalipoproteinemias

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
'TOPROL-XL®' ER Tablets 200 mg of Astrazeneca LP, USA

Group II

Experimental
Metoprolol Succinate ER Tablet 200 mg of Ipca Laboratories Limited, India

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cliantha Research Limited

Ahmedabad, IndiaOpen Cliantha Research Limited in Google Maps
CompletedOne Study Center