HealthyPhase 1NCT03051685
Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults
A Phase 1 study testing DFN-15 Dose 1, DFN-15 Dose 2 and DFN-15 Dose 3 in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to determine dose-proportionality of DFN-15 in healthy volunteers 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?
- DFN-15 Dose 1, DFN-15 Dose 2 and DFN-15 Dose 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2015to 10 Nov 2015
- 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
- Subjects were male or female, at least 18 years of age but not older than 45 years of age. The main inclusion criteria were:
- non- or ex-smokers
- body mass index (BMI) ≥18.50 kg/m2 and <30.00 kg/m2
- no clinically significant abnormality found in the 12-lead ECG performed at study entry
- negative pregnancy test for female subjects
- healthy according to medical history, complete physical examination (including vital signs) and laboratory tests (general biochemistry, hematology, urinalysis, and coagulation)
- Fecal occult blood determination negative at screening
Who cannot join
- Females who were pregnant or were lactating
- Patients who had a history of allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), including patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, nasal polyps or Samter's triad
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases, neurological impairment or cognitive dysfunction that, in the opinion of the investigator, would compromise validity of informed consent, study participation and compliance or data collection
Show all 21Show fewer
- Presence of out-of-range cardiac intervals and/ or morphological changes suggestive of arrhythmias or ischaemic heart disease on the screening electrocardiogram (ECG) or other clinically significant ECG abnormalities
- History or current hypertension, bleeding disorders, ischaemic heart disease, stroke and/or cerebrovascular disease or renal disease
- History of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs
- Presence or history of gastric, duodenal or peptic ulcer or gastrointestinal bleeding
- Use of ASA or NSAIDs, or any product containing ASA or NSAIDs, in the previous 7 days before day 1 of this study
- Known presence of rare hereditary problems of galactose and /or lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- Maintenance therapy with any drug or significant history of drug dependency (including marijuana and medical marijuana) or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic) within 1 year
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive urine screening of alcohol and/or drugs of abuse
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B)) or anti Hepatitis C Virus (HCV (C)) tests
- Females who were pregnant according to a positive pregnancy test
- Volunteers who took an investigational product (in another clinical trial) in the previous 28 days before day 1 of this study or who had already participated in this clinical study
- Volunteers who donated plasma in the previous 14 days before day 1 of this study
- Donation of 500 mL or more of blood (American Red Cross, clinical studies, etc.) in the previous 56 days before day 1 of this study
Trial locations and contacts
1 site in 1 country.
About this study
Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions
- Conditions
- Healthy
- Being tested
- DFN-15 Dose 1, DFN-15 Dose 2, DFN-15 Dose 3, Active Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFN-15 Dose 1Drug
DFN-15 Dose 2Drug
DFN-15 Dose 3Drug
Active ComparatorDrug
| Study group | Role | What they receive |
|---|---|---|
| DFN-15 Dose 1 | Experimental | Not described Receives: Drug: DFN-15 Dose 1 |
| DFN-15 Dose 2 | Experimental | Not described Receives: Drug: DFN-15 Dose 2 |
| DFN-15 Dose 3 | Experimental | Not described Receives: Drug: DFN-15 Dose 3 |
| Active Comparator | Active comparator | Not described Receives: Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) parameters of DFN-15
DFN-15 maximum Plasma Concentration (Cmax)
Measured: Up to 72 hours
Pharmacokinetic (PK) parameters of DFN-15
Area under the curve (AUC) 0-15 min
Measured: 15 minutes
Pharmacokinetic (PK) parameters of DFN-15
Area under the curve (AUC) 0-30
Measured: 30 minutes
Pharmacokinetic (PK) parameters of DFN-15
Area under the curve (AUC) 0-1 hour
Measured: 1 hour
Pharmacokinetic (PK) parameters of DFN-15
Area under the curve (AUC) 0-2 hours
Measured: 2 hours
Pharmacokinetic (PK) parameters of DFN-15
Area under the curve (AUC) 0-T
Measured: Up to 72 hours
Pharmacokinetic (PK) parameters of DFN-15
Area under the curve (AUC) 0-RefTmax
Measured: Up to 72 hours
Pharmacokinetic (PK) parameters of DFN-15
Area under the curve (AUC) 0-∞
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start20 Jul 2015
- Primary completion14 Aug 2015
- Study completion10 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051685
- Sponsor's protocol ID
- DFN-15-CD-003
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pal A, Shenoy S, Gautam A, Munjal S, Niu J, Gopalakrishnan M, Gobburru J. Pharmacokinetics of DFN-15, a Novel Oral Solution of Celecoxib, Versus Celecoxib 400-mg Capsules: A Randomized Crossover Study in Fasting Healthy Volunteers. Clin Drug Investig. 2017 Oct;37(10):937-946. doi: 10.1007/s40261-017-0548-6.
PubMed 28748412
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of DFN-15 at 3 Different Doses vs. Comparator and to Determine Dose-proportionality of DFN-15 in Fasting Healthy Adults
- ClinicalTrials.gov ID
- NCT03051685
- Acronym / sponsor ID
- DFN-15-CD-003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2015 (actual)
- Primary completion
- 14 Aug 2015 (actual)
- Study completion
- 10 Nov 2015 (actual)
- First posted
- 14 Feb 2017 (actual)
- 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.
Crossover study to compare the BA of DFN-15 at 3 different doses versus the comparator to determine dose-proportionality of DFN-15 in healthy volunteers under fasting conditions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DFN-15 Dose 1 | Experimental | Drug: DFN-15 Dose 1 |
| DFN-15 Dose 2 | Experimental | Drug: DFN-15 Dose 2 |
| DFN-15 Dose 3 | Experimental | Drug: DFN-15 Dose 3 |
| Active Comparator | Active comparator | Drug: Active Comparator |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects were male or female, at least 18 years of age but not older than 45 years of age. The main inclusion criteria were:
- non- or ex-smokers
- body mass index (BMI) ≥18.50 kg/m2 and <30.00 kg/m2
- no clinically significant abnormality found in the 12-lead ECG performed at study entry
- negative pregnancy test for female subjects
Key exclusion criteria (21 listed)
- Females who were pregnant or were lactating
- Patients who had a history of allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), including patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, nasal polyps or Samter's triad
- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
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 |
|---|---|---|
| DFN-15 Dose 1 | Drug | DFN-15 Dose 1 |
| DFN-15 Dose 2 | Drug | DFN-15 Dose 2 |
| DFN-15 Dose 3 | Drug | DFN-15 Dose 3 |
| Active Comparator | Drug | Active Comparator |
Primary outcome
Pharmacokinetic (PK) parameters of DFN-15
Time frame: Up to 72 hours
DFN-15 maximum Plasma Concentration (Cmax)
Pharmacokinetic (PK) parameters of DFN-15
Time frame: 15 minutes
Area under the curve (AUC) 0-15 min
Pharmacokinetic (PK) parameters of DFN-15
Time frame: 30 minutes
Area under the curve (AUC) 0-30
Pharmacokinetic (PK) parameters of DFN-15
Time frame: 1 hour
Area under the curve (AUC) 0-1 hour
Pharmacokinetic (PK) parameters of DFN-15
Time frame: 2 hours
Area under the curve (AUC) 0-2 hours
Pharmacokinetic (PK) parameters of DFN-15
Time frame: Up to 72 hours
Area under the curve (AUC) 0-T
Pharmacokinetic (PK) parameters of DFN-15
Time frame: Up to 72 hours
Area under the curve (AUC) 0-RefTmax
Pharmacokinetic (PK) parameters of DFN-15
Time frame: Up to 72 hours
Area under the curve (AUC) 0-∞
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 13 Feb 2018.
- Results publication: PubMed 28748412Pal A, Shenoy S, Gautam A, Munjal S, Niu J, Gopalakrishnan M, Gobburru J. Pharmacokinetics of DFN-15, a Novel Oral Solution of Celecoxib, Versus Celecoxib 400-mg Capsules: A Randomized Crossover Study in Fasting Healthy Volunteers. Clin Drug Investig. 2017 Oct;37(10):937-946. doi: 10.1007/s40261-017-0548-6.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
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 Phase 1 study testing DFN-15 Dose 1, DFN-15 Dose 2 and DFN-15 Dose 3 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 7 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 13 Feb 2018. 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?
Pharmacokinetic (PK) parameters of DFN-15 (time frame: Up to 72 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03051685, which also lists 1 linked publication.
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 13 Feb 2018.