HealthyPhase 1NCT01131767
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions
A Phase 1 study testing Naproxen Sodium & Pseudoephedrine HCl in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Naproxen Sodium & Pseudoephedrine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2004to Sep 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fed conditions.
Read the detailed description
Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26 healthy human adult subjects under fed conditions with a washout period of 27 days.
- Conditions
- Healthy
- Being tested
- Naproxen Sodium & Pseudoephedrine HCl
- Keywords
- Bioequivalence, Crossover, Naproxen Sodium and Pseudoephedrine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen Sodium & Pseudoephedrine HClDrug
Also called Aleve Cold and Sinus
Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
| Study group | Role | What they receive |
|---|---|---|
| Naproxen Sodium & Pseudoephedrine HCl | Experimental | Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg ER Tablets of Dr. Reddy's Laboratories. Receives: Drug: Naproxen Sodium & Pseudoephedrine HCl |
| Aleve Cold and Sinus | Active comparator | Aleve Cold and Sinus(Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets). Receives: Drug: Naproxen Sodium & Pseudoephedrine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startJul 2004
- Primary completionAug 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sandhya Ravi, MBBS, MS., Principal investigator, Lotus Labs Pvt. Ltd.,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131767
- Sponsor's protocol ID
- 398/04
- Status last verified
- Jun 2010
- First submitted
- 26 May 2010
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01131767
- Acronym / sponsor ID
- 398/04
- Conditions
- Healthy
- Keywords
- Bioequivalence, Crossover, Naproxen Sodium and Pseudoephedrine Hydrochloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 27 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fed conditions.
Detailed description
Open randomized, two treatment, two period, two sequence, single dose, crossover study of 26 healthy human adult subjects under fed conditions with a washout period of 27 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen Sodium & Pseudoephedrine HCl | Experimental | Drug: Naproxen Sodium & Pseudoephedrine HClNaproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg ER Tablets of Dr. Reddy's Laboratories. |
| Aleve Cold and Sinus | Active comparator | Drug: Naproxen Sodium & Pseudoephedrine HClAleve Cold and Sinus(Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen Sodium & Pseudoephedrine HClAlso: Aleve Cold and SinusNaproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets | Drug | Aleve Cold and Sinus, Naproxen Sodium & Pseudoephedrine HCl |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandhya Ravi, MBBS, MS. principal investigator
Lotus Labs Pvt. Ltd.,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naproxen Sodium & Pseudoephedrine HCl in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Cmax and AUC parameters (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.