HealthyNCT00779805
Bioequivalence Study of Pseudoephedrine HCl 120 mg ER Tablets Under Fed Conditions
A study testing Pseudoephedrine hydrochloride 120 mg ER tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
Trial summary
The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pseudoephedrine hydrochloride 120 mg ER tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2004to Oct 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be in the age range of 18 - 45 years
- Be neither over weight nor under weight for his/ her height as per the Life Insurance Corporation of India height/ weight chart for non-medical cases
- Have voluntarily given written informed consent to participate in this study
- Be of normal health as determined by medical history and physical examination of the subjects performed within 14 days prior to the commencement of the study
- If female and:
- Of child bearing potential is 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; or
- Is postmenopausal for at least 1 year; or
- Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Who cannot join
- History of allergy to Pseudoephedrine or other sympathomimetic drugs
- History of intake of any sympathomimetic drugs and glucocorticoids during a period of 15 days prior to day 1 of this study.
- Concurrent use of monoamine oxidase inhibitor (MAOI) drugs within 14 days prior to day 1 of this study
- Any evidence of organ dysfunction or any clinically significant deviations from the normal, in physical or clinical determinations
- Presence of disease markers of HIV 1 or 2, hepatitis B or C viruses or syphilis infection
- Female volunteers demonstrating a positive pregnancy test
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- Female volunteers who are currently breastfeeding
- Presence of values which are significantly different from normal reference ranges (as defined in appendix 5) and/ or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/ HPF), glucose (positive) or protein (positive)
- Clinically abnormal ECH or chest X-ray
- History of serious gastrointestinal, hepatic, renal, pulmonary, neurological or hematological diseases or glaucoma
- History of cardiovascular disorders (including hypertension), endocrine disorders, hyperthyroidism, diabetes mellitus, prostatic hypertrophy, palpitations, insomnia, tremors or bronchial asthma
- History of any psychiatric illness which may impair the ability to provide written informed consent
- Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period
- Use of any enzyme modifying drugs within 30 days prior to day 1 of this study
- Participation in any clinical trail within 12 weeks preceding day 1 of this study
- Subjects who, through completion of this study, would have donated and / or lost more than 350 mL of blood in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With Sudafed 120 mg ER Tablets of Pfizer Consumer Health Care in Healthy, Adult, Human Subjects Under Fed Conditions.
The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.
Read the detailed description
This study was an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioavailability study planned on 40 healthy, adult, human subjects under fed conditions.
A total of forty (40) healthy, adult, human subjects were admitted in the study to allow the dosing in the first period. Out of the forty subjects, only thirty eight (38) subjects completed both the periods of the study.
- Conditions
- Healthy
- Being tested
- Pseudoephedrine hydrochloride 120 mg ER tablets
- Keywords
- Bioequivalence Pseudoephedrine hydrochloride 120 mg ER tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pseudoephedrine hydrochloride 120 mg ER tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy Receives: Drug: Pseudoephedrine hydrochloride 120 mg ER tablets |
| 2 | Active comparator | Sudafed 120 mg ER tablets Receives: Drug: Pseudoephedrine hydrochloride 120 mg ER 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 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779805
- Sponsor's protocol ID
- 016/ PSEUD-120/ 04
- 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
- An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With Sudafed 120 mg ER Tablets of Pfizer Consumer Health Care in Healthy, Adult, Human Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT00779805
- Acronym / sponsor ID
- 016/ PSEUD-120/ 04
- Conditions
- Healthy
- Keywords
- Bioequivalence Pseudoephedrine hydrochloride 120 mg ER tablets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Oct 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.
The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.
Detailed description
This study was an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioavailability study planned on 40 healthy, adult, human subjects under fed conditions.
A total of forty (40) healthy, adult, human subjects were admitted in the study to allow the dosing in the first period. Out of the forty subjects, only thirty eight (38) subjects completed both the periods of the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Pseudoephedrine hydrochloride 120 mg ER tabletsPseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy |
| 2 | Active comparator | Drug: Pseudoephedrine hydrochloride 120 mg ER tabletsSudafed 120 mg ER tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Be in the age range of 18 - 45 years
- Be neither over weight nor under weight for his/ her height as per the Life Insurance Corporation of India height/ weight chart for non-medical cases
- Have voluntarily given written informed consent to participate in this study
- Be of normal health as determined by medical history and physical examination of the subjects performed within 14 days prior to the commencement of the study
- If female and:
Key exclusion criteria (18 listed)
- History of allergy to Pseudoephedrine or other sympathomimetic drugs
- History of intake of any sympathomimetic drugs and glucocorticoids during a period of 15 days prior to day 1 of this study.
- Concurrent use of monoamine oxidase inhibitor (MAOI) drugs within 14 days prior to day 1 of this study
- Any evidence of organ dysfunction or any clinically significant deviations from the normal, in physical or clinical determinations
- Presence of disease markers of HIV 1 or 2, hepatitis B or C viruses or syphilis infection
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 |
|---|---|---|
| Pseudoephedrine hydrochloride 120 mg ER 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 Pseudoephedrine hydrochloride 120 mg ER tablets in people with Healthy, run by Ranbaxy 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 18 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 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.
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.