HealthyPhase 1NCT01132222
Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions
A Phase 1 study testing Ibuprofen + Pseudoephedrine Hydrochloride 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 Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibuprofen + Pseudoephedrine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2004to Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (II Underweight and Overweight Min. \& Max. Chart)
- Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- Informed consent given in written form according to section 10.3 of the protocol.
- Female Subjects:
- of child bearing potential practicing an acceptable method of birth control for the duration of study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- postmenopausal for at least 1 year.
- surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.
Who cannot join
- 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 on assumption of tobacco products.
- History of difficulty in swallowing.
- Clinically significant illness within 4 weeks before the start of the study
Show all 21Show fewer
- 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 - 800 m l 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
- Participation in another clinical trial within the preceding 28 days of study start.
- Subjects who have:
- Systolic blood pressure less than 90 mm of Hg and more than 150 mm of Hg
- Diastolic blood pressure less than 60 m 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, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fed Conditions.
The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions.
Read the detailed description
This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy human adult subjects with the single oral administration under fed conditions with a washout period of 7 days.
- Conditions
- Healthy
- Being tested
- Ibuprofen + Pseudoephedrine Hydrochloride
- Keywords
- Bioequivalence, Crossover, Ibuprofen and Pseudoephedrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen + Pseudoephedrine HydrochlorideDrug
Also called Advil® Cold and Sinus
Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen + Psuedoephedrine Hydrochloride | Experimental | Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Receives: Drug: Ibuprofen + Pseudoephedrine Hydrochloride |
| Advil® Cold and Sinus | Active comparator | Advil® Cold and Sinus Tablets of Wyeth Consumer Healthcare Receives: Drug: Ibuprofen + Pseudoephedrine Hydrochloride |
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: 2 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 startSep 2004
- Primary completionOct 2004
- Study completionOct 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vijayanthi G, MBBS, MD, Principal investigator, Lotus Labs Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132222
- Sponsor's protocol ID
- 431-04
- Status last verified
- Jun 2010
- First submitted
- 26 May 2010
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
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, 2-treatment, Single Dose, Crossover, Bioequivalence Study of Ibuprofen 200 mg+Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01132222
- Acronym / sponsor ID
- 431-04
- Conditions
- Healthy
- Keywords
- Bioequivalence, Crossover, Ibuprofen and Pseudoephedrine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 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 Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions.
Detailed description
This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy human adult subjects with the single oral administration under fed conditions with a washout period of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen + Psuedoephedrine Hydrochloride | Experimental | Drug: Ibuprofen + Pseudoephedrine HydrochlorideIbuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets |
| Advil® Cold and Sinus | Active comparator | Drug: Ibuprofen + Pseudoephedrine HydrochlorideAdvil® Cold and Sinus Tablets of Wyeth Consumer Healthcare |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy human subjects between 18-50 years of age (inclusive), weighing as per the standard height and weight chart of Life Insurance Corporation of India (II Underweight and Overweight Min. \& Max. Chart)
- Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- Informed consent given in written form according to section 10.3 of the protocol.
- Female Subjects:
Key exclusion criteria (21 listed)
- History or presence of significant:
- Subjects who, through completion of the study, would have donated in excess of
- Participation in another clinical trial within the preceding 28 days of study start.
- Subjects who have:
- Female volunteers demonstrating a positive pregnancy screen or currently breast-feeding.
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 |
|---|---|---|
| Ibuprofen + Pseudoephedrine HydrochlorideAlso: Advil® Cold and SinusIbuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets | Drug | Advil® Cold and Sinus, Ibuprofen + Psuedoephedrine Hydrochloride |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 2 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.
Vijayanthi G, MBBS, MD 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 Ibuprofen + Pseudoephedrine Hydrochloride 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 8 inclusion and 21 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: 2 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.