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

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ClinicalTrials.gov Identifier: NCT03706300
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : December 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015


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
Drug: Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg
Other Name: Mucinex D

Active Comparator: Mucinex D
Mucinex D extended-release bi-layer tablets 1200/120 mg of Reckitt Benckiser Inc., USA
Drug: Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg
Other Name: Mucinex D




Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706300


Locations
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India
QPS Bioserve India Pvt. Limited
Hyderabad, Telangana, India, 500 037
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Dr. K. Krishna Moorthy, MBBS QPS Bioserve India Pvt. Limited

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03706300     History of Changes
Other Study ID Numbers: 641-14
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Pseudoephedrine
Phenylpropanolamine
Ephedrine
Chlorpheniramine, phenylpropanolamine drug combination
Guaifenesin
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Expectorants
Adrenergic alpha-Agonists
Adrenergic Agonists
Appetite Depressants
Anti-Obesity Agents