HealthyPhase 1NCT01506791
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
A Phase 1 study testing Desloratadine and pseudoephedrine in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
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
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 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
- Is the individual a healthy, normal adult man or woman who volunteers to participate?
- Is s/he within 18 to 45 years of age, inclusive?
- Is his/her BMI between 19 and 30 inclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
- Has s/he provided written informed consent?
Who cannot join
- Does the individual have a history or allergy or hypersensitivity to desloratadine or pseudoephedrine, milk or eggs?
- Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
- Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse?
Show all 14Show fewer
- Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test?
- Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period?
- Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation?
- Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
- Has s/he donated or lost blood or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
- Has s/he donated plasma during the two week period preceding study initiation?
- Has s/he received an investigational drug during the 30 day period preceding study initiated?
- Has s/he used any tobacco products in the 3 months preceding 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 Fed 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 fed conditions. The treatment phases were separated by a washout period of 14 days. 44 subjects were dosed and were enrolled in the study; 43 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.
Area under curve(AUC)
Measured: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startApr 2006
- Study completionApr 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio R Pizarro, MD, Principal investigator, SFBC Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506791
- Sponsor's protocol ID
- 50631
- Status last verified
- Jun 2006
- First submitted
- 27 Sep 2011
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. 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 Fed Conditions
- ClinicalTrials.gov ID
- NCT01506791
- Acronym / sponsor ID
- 50631
- Conditions
- Healthy
- Keywords
- Bioequivalence, Desloratadine and pseudoephedrine, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Apr 2006 (actual)
- First posted
- 10 Jan 2012 (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 fed conditions. The treatment phases were separated by a washout period of 14 days. 44 subjects were dosed and were enrolled in the study; 43 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 (6 listed)
- Is the individual a healthy, normal adult man or woman who volunteers to participate?
- Is s/he within 18 to 45 years of age, inclusive?
- Is his/her BMI between 19 and 30 inclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and role in the study?
Key exclusion criteria (14 listed)
- Does the individual have a history or allergy or hypersensitivity to desloratadine or pseudoephedrine, milk or eggs?
- Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
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
Area under curve(AUC)
Time frame: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose
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 10 Jan 2012.
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.
Antonio R Pizarro, 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 United States.
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 6 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 10 Jan 2012. 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 United States. 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?
Area under curve(AUC) (time frame: Pre-dose 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,7,8,9,10,12,24,36,48,72,96,120 and 144 hours post-dose). 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 10 Jan 2012.