HealthyNCT00779831
Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions
A study testing 120 mg Pseudoephedrine hydrochloride extended release tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
Trial summary
Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg (Warner-Lambert) under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 120 mg Pseudoephedrine hydrochloride extended release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2004to Dec 2004
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All subjects enrolled in this study met all inclusion and exclusion criteria, and were judged by the investigator to be normal, healthy volunteers
- Subjects were included in the study if they met all of the following criteria:
- Healthy adult male or female volunteers , 18 to 55 years of age
- Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of 'Desirable Weights of Adults', Metropolitan Life Insurance Company, 1983)
- Medically healthy subjects with clinically normal laboratory profiles and ECGs
- Females of child bearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
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- Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum
- IUD in place for at least 3 months
- Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study
- Surgical sterilization of the partner (vasectomy for 6 months minimum)
- Hormonal contraceptives for at least 3 months prior to the first dose of the study
- Other birth control methods may be deemed acceptable
- Post menopausal women with amenorrhea for at least 2 years will be eligible
- Voluntarily consent to participate in the study
Who cannot join
- Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
- In addition, history or presence of:
- Alcoholism or drug abuse within the past year
- Hypersensitivity or idiosyncratic reaction to Pseudoephedrine or any other sympathomimetic amines
- Glaucoma or hypermetropia
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- Female subjects who are pregnant or lactating
- Positive results on HIV, HbsAg and HCV tests
- Subjects receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor, or any sympathomimetic amines
- Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study
- Subjects who through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days
- 1500 mL of blood in 180 days
- 2500 mL of blood in 1 year. 8. Subjects who have participated in another clinical trial within 28 days prior to the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Randomized, Single Dose, 2 Way Crossover Bioavailability Study of Ranbaxy and Warner - Lambert (Sudafed ® 12 Hour) 120 mg Pseudoephedrine Hydrochloride Extended - Release Tablets in Healthy Adult Volunteers Under Fasting Conditions.
Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg (Warner-Lambert) under fasting conditions.
Read the detailed description
This was an open label, randomized, single dose, 2-way crossover, relative bioavailability study performed on a total of 36 healthy adult subjects (20 males and 16 females). Thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36 hour blood draw. Single oral 120 mg Pseudoephedrine hydrochloride doses were separated by a washout period of 7 days.
A total of thirty six (36) subjects (20 males and 16 females) were enrolled in the study. Out of which a total of thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study.
- Conditions
- Healthy
- Being tested
- 120 mg Pseudoephedrine hydrochloride extended release tablets
- Keywords
- Bioequivalence Pseudoephedrine hydrochloride 120 mg extended release tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
120 mg Pseudoephedrine hydrochloride extended release tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 120 mg Pseudoephedrine hydrochloride extended release tablets of ranbaxy Receives: Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets |
| 2 | Active comparator | (Sudafed ® 12 hour) 120 mg Pseudoephedrine hydrochloride extended - release tablets Receives: Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJun 2004
- Primary completionJun 2004
- Study completionDec 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779831
- Sponsor's protocol ID
- AA16795
- Status last verified
- Oct 2008
- First submitted
- 23 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single Dose, 2 Way Crossover Bioavailability Study of Ranbaxy and Warner - Lambert (Sudafed ® 12 Hour) 120 mg Pseudoephedrine Hydrochloride Extended - Release Tablets in Healthy Adult Volunteers Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00779831
- Acronym / sponsor ID
- AA16795
- Conditions
- Healthy
- Keywords
- Bioequivalence Pseudoephedrine hydrochloride 120 mg extended release tablets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 24 Oct 2008 (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.
Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg (Warner-Lambert) under fasting conditions.
Detailed description
This was an open label, randomized, single dose, 2-way crossover, relative bioavailability study performed on a total of 36 healthy adult subjects (20 males and 16 females). Thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36 hour blood draw. Single oral 120 mg Pseudoephedrine hydrochloride doses were separated by a washout period of 7 days.
A total of thirty six (36) subjects (20 males and 16 females) were enrolled in the study. Out of which a total of thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets120 mg Pseudoephedrine hydrochloride extended release tablets of ranbaxy |
| 2 | Active comparator | Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets(Sudafed ® 12 hour) 120 mg Pseudoephedrine hydrochloride extended - release tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- All subjects enrolled in this study met all inclusion and exclusion criteria, and were judged by the investigator to be normal, healthy volunteers
- Healthy adult male or female volunteers , 18 to 55 years of age
- Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of 'Desirable Weights of Adults', Metropolitan Life Insurance Company, 1983)
- Medically healthy subjects with clinically normal laboratory profiles and ECGs
- Females of child bearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
Key exclusion criteria (14 listed)
- Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:
- 500 mL of blood in 14 days
- 1500 mL of blood in 180 days
- 2500 mL of blood in 1 year. 8. Subjects who have participated in another clinical trial within 28 days prior to the first dose.
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 |
|---|---|---|
| 120 mg Pseudoephedrine hydrochloride extended release tablets | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 24 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 120 mg Pseudoephedrine hydrochloride extended release tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
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 14 inclusion and 14 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 24 Oct 2008. 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 Canada. 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.
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. 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 24 Oct 2008; AzTrials last refreshed its copy on 6 Nov 2026.