HealthyNCT00837915
Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions
A study testing Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in Canada.
Trial summary
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions. 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?
- Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release 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 siteCanada
- Study dates
- Jun 2002to Nov 2002
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female volunteers, 18-45 years of age
- Weighing at least 60 kg for males and 52 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;
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
- surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum
- IUD in place for at least 3 months
Show all 12Show fewer
- barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and .throughout the study
- surgical sterilization of the partner (vasectomy for 6 months minimum
- hormonal contraceptives for at least 3 months prior to the start of the study
- Other birth control methods may be deemed acceptable.
- Postmenopausal women with amenorrhea for at least 2 years will be eligible;
- Voluntarily consent to participate in the study.
Who cannot join
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- 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 loratidine or any other H1-receptor antagonist
- hypersensitivity or idiosyncratic reaction to pseudoephederine or any other sympatomimetic amines
Show all 21Show fewer
- glaucoma or hypermetropia
- 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 used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
- Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days of study start.
- Female subjects who are pregnant or lactating.
- Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dose.
- Subjects who, through completition of the study, would have donated in excess of:
- 500 mL of blood in 14 days, or
- 500-750 mL 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 days,
- Subjects who have participated in another clinical trial within 28 days prior to the study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy Adult Volunteers Under Fasting Conditions
The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.
Read the detailed description
The study was conducted as an open-label, randomized, Single-Dose, Fully replicated, 4-way Crossover Study to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin_D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy adult Volunteers Under Fasting Conditions A total of 40 subjects (30 males and 10 females) were included in this study, of which 36 (27 males and 9 females) finished the study according to the protocol.
- Conditions
- Healthy
- Being tested
- Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets
- Keywords
- Bioequivaelnce Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended Release Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release TabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets of Ranbaxy Receives: Drug: Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets |
| 2 | Active comparator | (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets Receives: Drug: Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fasting conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startJun 2002
- Primary completionAug 2002
- Study completionNov 2002
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
- NCT00837915
- Sponsor's protocol ID
- AA01111
- Status last verified
- Feb 2009
- First submitted
- 8 Jan 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single-Dose, Fully Replicated, 4-Way Crossover Bioavailability Study of Ranbaxy and Schering (Claritin_D® 24 Hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy Adult Volunteers Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00837915
- Acronym / sponsor ID
- AA01111
- Conditions
- Healthy
- Keywords
- Bioequivaelnce Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended Release Tablets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 6 Feb 2009 (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 this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.
Detailed description
The study was conducted as an open-label, randomized, Single-Dose, Fully replicated, 4-way Crossover Study to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin_D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in Healthy adult Volunteers Under Fasting Conditions A total of 40 subjects (30 males and 10 females) were included in this study, of which 36 (27 males and 9 females) finished the study according to the protocol.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release TabletsLoratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets of Ranbaxy |
| 2 | Active comparator | Drug: Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets(Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adult male or female volunteers, 18-45 years of age
- Weighing at least 60 kg for males and 52 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;
- Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
- Other birth control methods may be deemed acceptable.
Key exclusion criteria (21 listed)
- Subject candidates must not be enrolled in the study if they meet any of the following criteria:
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- 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 used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days of study start.
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 |
|---|---|---|
| Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets | Drug | 1, 2 |
Primary outcome
Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fasting conditions
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 6 Feb 2009.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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.
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 Loratadine 10mg /Pseudoephedrine Sulfate 240 mg 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 12 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 6 Feb 2009. 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?
Relative bioavailability between Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets under fasting conditions. 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 6 Feb 2009.