- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01131767
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fed Conditions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Karnataka
-
Bangalore, Karnataka, India, 560034
- Lotus Labs Private Limited
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
- Subjects will provide written informed consent.
- Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
- Subjects must be within ±15% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non- medical cases.
- Subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study.
- Have normal ECG, X-ray and vital signs.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
If subject is a female volunteer and
- Is 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.
- Is postmenopausal for at least 1 year.
- Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.
Exclusion Criteria:
The subjects will be excluded under following conditions:
History or presence of significant:
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine,immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse within past one year.
- Moderate to heavy smoking (>10 cigarettes/day) or consumption of tobacco products.
- Asthma, urticaria or other allergic type reactions after taking any medication.
Subjects who through completion of the study, would have donated in excess of
- 500 ml of blood in 14 days, or
- 500 - 800ml of blood in 14 days (unless approved by the Principal Investigator)
- 1000 ml of blood in 90 days
- 1250 ml of blood in 120 days
- 1500 ml of blood in 180 days
- 2000 ml of blood in 270 days
- 2500 ml of blood in 1 year
Subjects who have participated in another clinical trial within 3 months of study start.
Subjects who have:
- Systolic blood pressure less than 90 mm of Hg and higher than 150 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg and more than 95 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician/investigator.
- Pulse rate below 50/min. and above 105/min. Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
Study Plan
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: Naproxen Sodium & Pseudoephedrine HCl
Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg ER Tablets of Dr. Reddy's Laboratories.
|
Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
Other Names:
|
Active Comparator: Aleve Cold and Sinus
Aleve Cold and Sinus(Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets).
|
Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence based on Cmax and AUC parameters
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Malnutrition
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Central Nervous System Stimulants
- Gout Suppressants
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Ephedrine
- Pseudoephedrine
- Naproxen
Other Study ID Numbers
- 398/04
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Naproxen Sodium & Pseudoephedrine HCl
-
Dr. Reddy's Laboratories LimitedCompleted
-
Johnson & Johnson Consumer Inc., McNeil Consumer...Completed
-
BayerCompletedPain, PostoperativeUnited States
-
Johnson & Johnson Consumer Inc., McNeil Consumer...Completed
-
Genta IncorporatedCompleted
-
Huazhong University of Science and TechnologyWithdrawnType1 Diabetes MellitusChina
-
SanofiCompleted
-
Johnson & Johnson Consumer Inc., McNeil Consumer...CompletedPost-operative Dental PainUnited States
-
Genta IncorporatedCompleted