Bioequivalence Study for Metoprolol Succinate ER Tablets 50 mg Under Fasting Condition

NCT ID: NCT01694797

Last Updated: 2012-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-01-31

Brief Summary

The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 50 mg under fasting conditions

Detailed Description

An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Metoprolol Succinate Extended-Release tablets 50 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metoprolol Succinate ER Tablets, 50 mg

Metoprolol Succinate ER Tablets, 50 mg of Dr.Reddy's Laboratories Ltd

Group Type: EXPERIMENTAL

Metoprolol Succinate

Intervention Type: DRUG

TOPROL-XL ER Tablets 50 mg

TOPROL-XL ER Tablets 50 mg of AstraZeneca

Group Type: ACTIVE_COMPARATOR

Metoprolol Succinate

Intervention Type: DRUG

Interventions

Metoprolol Succinate

Intervention Type: DRUG

Other Intervention Names

TOPROL-XL®

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent.
• Must be healthy, adult, human beings between 18 and 45 years of age(both inclusive) weighing at least 50 kg.
• Having a body mass index between 18.5 and 24.9 (both inclusive),calculated as weight in Kg/height in m2
• Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study.(Laboratory values must be within normal limits or considered by the physician/investigator to be of no clinical significance).
• Female Subjects of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s),such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
• surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria

The subjects were excluded based on the following criteria during screening and during the study:

• Incapable of understanding the informed consent.
• Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
• Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
• Oral temperature is below 95.0°F or above 98.6°F.
• Pulse rate below 50/min or above 100/min.
• History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
• Consumption of grapefruit for the past ten days prior to the check-in, in each period.
• Habit of tobacco chewing.
• Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
• Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
• Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
• Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
• Clinically significant abnormalities and lor with significant diseases.
• Confirmed positive in alcohol screening.
• Confirmed positive in selected drug of abuse.
• Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
• Confirmed positive in urine pregnancy test.
• Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. P. Vijaya Lakshmi, Clinical Investigator

Role: PRINCIPAL_INVESTIGATOR

Bioserve Clinical Research Private Limited

Locations

Bioserve Clinical Research Private Limited

Hyderabad, Andhra Pradesh, India

Countries

India

Other Identifiers

642/09

Identifier Type: -

Identifier Source: org_study_id