Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions

October 11, 2018 updated by: Dr. Reddy's Laboratories Limited

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg of Dr. Reddy's Laboratories Ltd., India Comparing With Mucinex D (Guaifenesin and Pseudoephedrine Hydrochloride) Extended-release Bi-layer Tablets 1200/120 mg of Reckitt Benckiser Inc., USA in Healthy, Adult, Human Subjects Under Fasting Conditions.

This is an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.

Study Overview

Detailed Description

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg of Dr. Reddy's Laboratories Ltd., India comparing with Mucinex D (Guaifenesin and Pseudoephedrine Hydrochloride) extended-release bi-layer tablets 1200/120 mg of Reckitt Benckiser Inc., USA in healthy, adult, human subjects under fasting conditions.

Study Type

Interventional

Enrollment (Actual)

80

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

    • Telangana
      • Hyderabad, Telangana, India, 500 037
        • QPS Bioserve India Pvt. 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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

i. Volunteers who provide written informed consent.

ii. Must be healthy, adult, humans between 18 and 45 years of age (both inclusive) weighing at least 55 kg.

iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2.

iv. 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).

v. Female Subjects

  1. 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, or abstinence.
  2. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

i. Incapable of understanding the informed consent.

ii. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.

iii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.

iv. Oral temperature is below 95.0°F or above 98.6°F.

v. Pulse rate below 60/min or above 100/min.

vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.

vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.

viii. Any evidence of hematological, immunological, endocrinological, dermatological, neurological, musculoskeletal and psychiatric conditions.

ix. Consumption of grapefruit for the past ten days prior to the check-in, in each period.

x. 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.

xi. Habit of alcoholism and difficulty in abstaining from alcohol 24 hours before the drug administration and throughout the sample collection period.

xii. Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) 24 hours before the drug administration and throughout the sample collection period.

xiii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing and until last blood sample of the study.

xiv. Difficulty in swallowing tablets.

xv. Confirmed positive in alcohol screening.

xvi. Confirmed positive in selected drug of abuse.

xvii. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.

xviii. Female confirmed positive in urine pregnancy test.

xix. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.

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
Experimental: Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets
Guaifenesin and Pseudoephedrine Hydrochloride ER Tablets 1200/120 mg of Dr. Reddy's Laboratories Limited
Other Names:
  • Mucinex D
Active Comparator: Mucinex D
Mucinex D extended-release bi-layer tablets 1200/120 mg of Reckitt Benckiser Inc., USA
Other Names:
  • Mucinex D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under curve
Time Frame: Pre-dose (0.00), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post dose.
Pre-dose (0.00), 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 14.00, 16.00, 20.00, 24.00, 36.00 and 48.00 hours post dose.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Dr. K. Krishna Moorthy, MBBS, QPS Bioserve India Pvt 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 (Actual)

December 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

March 1, 2015

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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