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

NCT01884896 | Completed Phase 1 DMC

• 1 other identifier: BA1264350
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Bioequivalence is based on Cmax and AUC parameters.

  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

Study Arms (2)

'TOPROL-XL®' ER Tablets 200 mg

ACTIVE COMPARATOR

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

Drug: Metoprolol Succinate ER Tablet 200 mg; Drug: 'TOPROL-XL®' ER Tablets 200 mg

Metoprolol Succinate ER Tablet 200 mg

EXPERIMENTAL

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

Drug: Metoprolol Succinate ER Tablet 200 mg; Drug: 'TOPROL-XL®' ER Tablets 200 mg

Interventions

Metoprolol Succinate ER Tablet 200 mg DRUG

1 \* 200 mg tablet per day

Also known as: Test Product

'TOPROL-XL®' ER Tablets 200 mg; Metoprolol Succinate ER Tablet 200 mg

'TOPROL-XL®' ER Tablets 200 mg DRUG

1 \* 200 mg tablet per day

Also known as: Reference Product

'TOPROL-XL®' ER Tablets 200 mg; Metoprolol Succinate ER Tablet 200 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 45 years old, both inclusive.
• Sex: Males and/or non-pregnant, non-lactating females.
• BMI: 18.5 to 24.9 weight in kg/(height in meter)2 both inclusive;
• Able to communicate effectively with study personnel and willingness to follow the protocol requirements as evidenced by written informed consent.
• Able to give written informed consent to participate in the study.
• 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.

You may not qualify if:

• History of allergic responses to Metoprolol Succinate or other related drugs, or any of its formulation ingredients.
• Have significant diseases or clinically significant abnormal findings during screening, \[medical history, physical examination, laboratory evaluations, ECG, chest X-ray recording, obstetrics and gynecological history and examination along with PAP smear (for female volunteers) \& transvaginal ultrasonography (for female volunteers)\].
• Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
• History or presence of bronchial asthma.
• Use of any hormone replacement therapy within 3 months prior to study medication dosing.
• A depot injection or implant of any drug within 3 months prior to administration of study medication.
• Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
• History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
• 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.
• History of difficulty with donating blood or difficulty in accessibility of veins.
• History of allergic response to heparin.
• A positive hepatitis screen (includes subtypes B \& C).
• A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
• 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.
• History of difficulty in swallowing, or of any gastrointestinal disease which could affect drug absorption.

Sponsors & Collaborators

• IPCA Laboratories Ltd.: lead

Study Sites (1)

Cliantha Research Limited

Ahmedabad, Gujarat, 380054, India

Location

MeSH Terms

Conditions

Fasting

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Dr. Manish Singhal, M.B.B.S

  Cliantha Research Limited

  PRINCIPAL INVESTIGATOR

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: June 19, 2013
• First Posted: June 24, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

IN (1)