HealthyPhase 1NCT01373138
Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions
A Phase 1 study testing Desloratadine and pseudoephedrine in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
Trial summary
This is an open label randomised, 2-way crossover, comparative bioequivalence study. 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?
- Desloratadine and pseudoephedrine
- 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 siteCanada
- Study dates
- Apr 2006to May 2006
- 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
- Male or female, non-smoker, ≥18 and ≤45 years of age.
- Capable of consent.
- Medically healthy with clinically normal laboratory profile, vital signs and ECG.
- BMI ≥19.0 and ≤30.0.
Who cannot join
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Positive test for hepatitis B, hepatitis C, or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
Show all 29Show fewer
- Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
- Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
- History of allergic reactions to desloratadine, pseudoephedrine or other related drugs.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to dosing.
- Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g.diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
- Any clinically significant history or presence of neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptives.
- Difficulty to swallow study medication.
- Use of any tobacco products in the 3 months preceding drug administration.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
- ● A depot injection or an implant of any drug (other than hormonal contraceptives) within 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:
- 50 mL to 499 mL of whole blood within 30 days,
- more than 499 mL of whole blood within 56 days prior to drug administration.
- Hemoglobin lower than 140g/L for males and 125 g/L for females.
- History or known presence of narrow-angle glaucoma, urinary retention, renal impairment, coronary artery or ischemic heart disease, diabetes mellitus, prostatic hypertrophy and hyperthyroidism.
- Positive urine pregnancy test at screening.
- Breast-feeding subject.
- Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception are:
- intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration;
- condom or diaphragm + spermicide;
- hormonal contraceptives (starting at least 4 weeks prior to study drug administration).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fasting Conditions
This is an open label randomised, 2-way crossover, comparative bioequivalence study.
Read the detailed description
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation, U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg extended-release tablet under fasting conditions. The treatment phases were separated by a washout period of 14 days. 34 subjects(19 males and 15 females) were dosed and were enrolled in the study; 31 of these enrolled subjects completed the study.
- Conditions
- Healthy
- Being tested
- Desloratadine and pseudoephedrine
- Keywords
- Bioequivalence, Desloratadine and pseudoephedrine, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine and pseudoephedrineDrug
Also called Clarinex D-24
Desloratadine and pseudoephedrine 5/240 mg
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine and pseudoephedrine ER tablets 5/240 mg | Experimental | Desloratadine and pseudoephedrine ER tablets 5/240 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Desloratadine and pseudoephedrine |
| Clarinex D 24-hour | Active comparator | Clarinex D-24 of Schering Corporation Inc USA Receives: Drug: Desloratadine and pseudoephedrine |
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 posted14 Jun 2011 (estimated)
- Study startApr 2006
- Study completionMay 2006
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
- Dr.Denis Audet, MD, Principal investigator, SFBC Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373138
- Sponsor's protocol ID
- 50630
- Status last verified
- Jun 2006
- First submitted
- 10 Jun 2011
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, 2-Way Crossover, Bioequivalence Study of Desloratadine and Pseudoephedrine 5 mg/240 mg Extended-Release Tablet and Clarinex-D® 24-Hour (Reference) Following a 5 mg/240 mg Dose in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01373138
- Acronym / sponsor ID
- 50630
- Conditions
- Healthy
- Keywords
- Bioequivalence, Desloratadine and pseudoephedrine, crossover
- 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
- Apr 2006
- Study completion
- May 2006 (actual)
- First posted
- 14 Jun 2011 (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.
This is an open label randomised, 2-way crossover, comparative bioequivalence study.
Detailed description
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation, U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg extended-release tablet under fasting conditions. The treatment phases were separated by a washout period of 14 days. 34 subjects(19 males and 15 females) were dosed and were enrolled in the study; 31 of these enrolled subjects completed the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desloratadine and pseudoephedrine ER tablets 5/240 mg | Experimental | Drug: Desloratadine and pseudoephedrineDesloratadine and pseudoephedrine ER tablets 5/240 mg of Dr. Reddy's Laboratories Limited |
| Clarinex D 24-hour | Active comparator | Drug: Desloratadine and pseudoephedrineClarinex D-24 of Schering Corporation Inc USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, non-smoker, ≥18 and ≤45 years of age.
- Capable of consent.
- Medically healthy with clinically normal laboratory profile, vital signs and ECG.
- BMI ≥19.0 and ≤30.0.
Key exclusion criteria (29 listed)
- Clinically significant illness or surgery within 4 weeks prior to dosing.
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening.
- Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
- Positive test for hepatitis B, hepatitis C, or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
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 |
|---|---|---|
| Desloratadine and pseudoephedrineAlso: Clarinex D-24Desloratadine and pseudoephedrine 5/240 mg | Drug | Clarinex D 24-hour, Desloratadine and pseudoephedrine ER tablets 5/240 mg |
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 2011.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Dr.Denis Audet, MD principal investigator
SFBC Anapharm
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 Desloratadine and pseudoephedrine in people with Healthy, run by Dr. Reddy's 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 4 inclusion and 29 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 2011. 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.
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 2011.