Bioequivalence Study of Metoprolol Succinate ER Tablets, 200 mg Under Fasting Conditions

NCT01673997 | Completed Phase 1 DMC

• 1 other identifier: P-643/09
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to monitor adverse events, safety and tolerance Metoprolol Succinate Extended-Release Tablets 200 mg under fasting conditions

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  Pre-dose (0.00) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 18.00, 20.00, 24.00, 36.00 and 48.00 hours post-dose.

Study Arms (2)

Metoprolol Succinate ER Tablets, 200 mg

EXPERIMENTAL

Metoprolol Succinate ER Tablets, 200 mg of Dr.Reddy's Laboratories Ltd

Drug: Metoprolol Succinate

TOPROL-XL ER Tablets 200 mg

ACTIVE COMPARATOR

TOPROL-XL ER Tablets 200 mg of AstraZeneca

Drug: Metoprolol Succinate

Interventions

Metoprolol Succinate DRUG

Metoprolol Succinate ER Tablets 200 mg

Also known as: TOPROL-XL®

Metoprolol Succinate ER Tablets, 200 mg; TOPROL-XL ER Tablets 200 mg

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research Private Limited

Hyderabad, Andhra Pradesh, 500 037, India

Location

MeSH Terms

Interventions

Metoprolol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr. P. Vijaya Lakshmi, Clinical Investigator

  Bioserve Clinical Research Private 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: August 24, 2012
• First Posted: August 28, 2012
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 25, 2012

Record last verified: 2011-01

Locations

IN (1)