PharmacokineticsPhase 1NCT03766984
Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac
A Phase 1 study testing Diclofenac sodium 25 mg, Tramadol hydrochloride 25 mg and Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg in people with Pharmacokinetics, run by Grünenthal GmbH at 1 site in Mexico.
Trial summary
The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Diclofenac sodium 25 mg, Tramadol hydrochloride 25 mg and Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMexico
- Study dates
- 7 Jun 2015to 23 Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman between 18 and 55 years of age.
- Women with use of a barrier method as a contraceptive.
- Body mass index equal to or above 18.0 and equal to or less than 27.0 kilograms per square meter.
- Clinically healthy. If the clinical history, the registration of vital signs and the physical examination did not show abnormal deviations that avoid their participation in a clinical study.
- Without a history of allergic reactions to the study drug.
- Stable vital signs during the selection (heart rate, respiratory rate, blood pressure at rest and axillary body temperature).
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- Laboratory studies: complete blood count, blood chemistry of 24 items, urinalysis, anti-human immunodeficiency virus (HIV) 1, anti-HIV2, anti-hepatitis B surface antigen (HBs) and anti-hepatitis C virus (HCVs) antibodies, and serologic test for syphilis [Venereal Disease Research Laboratory test]) within normal ranges according to the reference laboratory, or that the deviations are not clinically significant. If the deviation has no clinical significance, it may be justified the inclusion of the participant to the clinical study. The age of the report of the clinical laboratory studies must not be greater than 3 months.
- Electrocardiogram (ECG) with no pathological alterations, with validity of no more than 3 months.
- The participant accepts the restrictions and indications described in the protocol and internal regulations.
- The participant has read and understood the relevant aspects of the clinical study and gives its authorization for participation by signing the informed consent form before inclusion on the clinical study and performing any procedure.
Who cannot join
- Findings in the clinical history, vital signs and/or physical examination that show abnormal conditions of the general state of health of the participant that avoid its participation in a clinical study.
- Recent exposure to the study drug between the 30 days prior or any other medication by prescription or self consumed between the 14 days prior to the start of the study, or that do not accept to avoid its consumption during the course of the study.
- Surgery during the 30 days prior to the start of the study.
- Suspicion or evidence of infection by Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
- Serologic test for syphilis (Venereal Disease Research Laboratory test) positive.
- Known hypersensitivity to any medication.
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- Blood donation equal to or above 1 unit (0.5 liters) during the 30 days prior to the selection.
- Participants who have special food requirements or food restrictions.
- Women in the breastfeeding period and/or pregnant.
- Positive results in the qualitative test of pregnancy in urine (only women).
- Positive result in the qualitative detection of drugs of abuse.
- Participation in a clinical study Phase 1, 2 or 3 or bioavailability/ bioequivalence studies during the 3 months previous to the selection.
- The participant does not give his or her authorization to participate in the study through the signing of an informed consent, or is not willing to follow the indications and/or restrictions of the protocol and rules of the procedure.
- The participant is vulnerable or potentially vulnerable by which cannot freely express his/her consent by subordination of the principal investigator or by coercion of any third party.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Non-pharmacokinetic Interaction Between Diclofenac 25 mg and 25 mg Tramadol With the Fixed-dose Combination Tablets of the Two Drugs Administered to Healthy Subjects of Both Genders in Fasting State
The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
Read the detailed description
After a screening period of about 2 weeks, 36 eligible healthy men and women were randomly allocated to receive 3 sequential treatments in the following order:
- a single dose of diclofenac followed by a single dose of the fixed-dose combination of diclofenac/tramadol followed by a single dose of tramadol
- a single dose of tramadol followed by a single dose of the fixed-dose combination of diclofenac/tramadol followed by a single dose of diclofenac.
There were washout periods of 7 days between treatments.
Sixteen blood samples were collected per participant: at pre-dose and 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 36 hours after administration of each of the study drugs.
The pharmacokinetic parameters and relative bioavailabilities of diclofenac and tramadol (and of the tramadol metabolite M1) were determined for the new fixed-dose combination product and were compared to the single compound reference products.
Furthermore, the safety (frequency of adverse events) and tolerability of the new fixed-dose combination of diclofenac 25 mg and 25 mg tramadol in healthy men and women was assessed.
- Conditions
- Pharmacokinetics
- Being tested
- Diclofenac sodium 25 mg, Tramadol hydrochloride 25 mg, Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg
- Keywords
- fixed-dose combination, diclofenac, tramadol, interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac sodium 25 mgDrug
Diclofenac sodium 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador)
Tramadol hydrochloride 25 mgDrug
Tramadol hydrochloride 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador)
Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mgDrug
Also called Adorlan (Trade Mark)
Fixed-dose combination tablet containing diclofenac sodium 25 mg and tramadol hydrochloride 25 mg (Laboratorios Tecnandina S.A., Ecuador)
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac 25 mg | Experimental | Participants receive 1 tablet of diclofenac sodium 25 mg with 250 milliliters of purified water. Receives: Drug: Diclofenac sodium 25 mg |
| Tramadol 25 mg | Experimental | Participants receive 1 tablet of tramadol hydrochloride 25 mg with 250 milliliters of purified water. Receives: Drug: Tramadol hydrochloride 25 mg |
| Diclofenac/Tramadol 25 mg/25 mg FDC | Experimental | Participants receive 1 fixed-dose combination tablet of diclofenac sodium 25 mg/tramadol hydrochloride 25 mg with 250 milliliters of purified water. Receives: Drug: Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of diclofenac
16 plasma samples were collected from pre-dose to 36 hours post-dose. Diclofenac concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Maximum plasma concentration (Cmax) of tramadol
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from the administration until the time t (AUC0-t) of diclofenac
16 plasma samples were collected from pre-dose to 36 hours post-dose. Diclofenac concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from the administration until the time t (AUC0-t) of tramadol
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Secondary outcomes (14)
Maximum plasma concentration (Cmax) of tramadol metabolite M1
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol M1 concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from the administration until the time t (AUC0-t) of tramadol metabolite M1
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol M1 concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from 0 to infinity (AUC0-inf) of tramadol
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from 0 to infinity (AUC0-inf) of tramadol metabolite M1
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol M1 concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from 0 to infinity (AUC0-inf) of diclofenac
16 plasma samples were collected from pre-dose to 36 hours post-dose. Diclofenac concentrations were determined using validated analytical methods.
Measured: From pre-dose to 36 hours post-dose
Time to maximum plasma concentration (Tmax) for tramadol
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tmax was calculated based on Cmax data for tramadol.
Measured: From pre-dose to 36 hours post-dose
Time to maximum plasma concentration (Tmax) for tramadol metabolite M1
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tmax was calculated based on Cmax data for tramadol M1.
Measured: From pre-dose to 36 hours post-dose
Time to maximum plasma concentration (Tmax) for diclofenac
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tmax was calculated based on Cmax data for diclofenac
Measured: From pre-dose to 36 hours post-dose
Elimination half life (t half) for tramadol
16 plasma samples were collected from pre-dose to 36 hours post-dose. t half was calculated based on plasma concentration data for tramadol.
Measured: From pre-dose to 36 hours post-dose
Elimination half life (t half) for tramadol metabolite M1
16 plasma samples were collected from pre-dose to 36 hours post-dose. T half was calculated based on plasma concentration data for tramadol M1.
Measured: From pre-dose to 36 hours post-dose
Elimination half life (t half) for diclofenac
16 plasma samples were collected from pre-dose to 36 hours post-dose. t half was calculated based on plasma concentration data for diclofenac.
Measured: From pre-dose to 36 hours post-dose
Elimination rate constant (KE) for tramadol
16 plasma samples were collected from pre-dose to 36 hours post-dose. KE will be calculated based on the plasma concentrations for tramadol.
Measured: From pre-dose to 36 hours post-dose
Elimination rate constant (KE) for tramadol metabolite M1
16 plasma samples were collected from pre-dose to 36 hours post-dose. KE was calculated based on the plasma concentrations for tramadol M1.
Measured: From pre-dose to 36 hours post-dose
Elimination rate constant (KE) for diclofenac
16 plasma samples were collected from pre-dose to 36 hours post-dose. KE will be calculated based on the plasma concentrations for diclofenac.
Measured: From pre-dose to 36 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 posted6 Dec 2018
- Study start7 Jun 2015
- Primary completion23 Jun 2015
- Study completion23 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Longitudinal, prospective, crossover, open, randomized, single-dose study with 3 periods, 2 sequences (ACB and BCA), and 3 treatments (A, B, and C) in healthy participants and under fasting conditions.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grünenthal Colombiana S.A.
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766984
- Sponsor's protocol ID
- DCLF/TRMD-GRNN-01
- Other IDs
- HP8001-01
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information available on the Grünenthal Web Site (see URL below for details)
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Non-pharmacokinetic Interaction Between Diclofenac 25 mg and 25 mg Tramadol With the Fixed-dose Combination Tablets of the Two Drugs Administered to Healthy Subjects of Both Genders in Fasting State
- ClinicalTrials.gov ID
- NCT03766984
- Acronym / sponsor ID
- DCLF/TRMD-GRNN-01
- Conditions
- Pharmacokinetics
- Keywords
- fixed-dose combination, diclofenac, tramadol, interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Grünenthal Colombiana S.A.
- Study start
- 7 Jun 2015 (actual)
- Primary completion
- 23 Jun 2015 (actual)
- Study completion
- 23 Jun 2015 (actual)
- First posted
- 6 Dec 2018 (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.
The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
Detailed description
After a screening period of about 2 weeks, 36 eligible healthy men and women were randomly allocated to receive 3 sequential treatments in the following order:
- a single dose of diclofenac followed by a single dose of the fixed-dose combination of diclofenac/tramadol followed by a single dose of tramadol
- a single dose of tramadol followed by a single dose of the fixed-dose combination of diclofenac/tramadol followed by a single dose of diclofenac.
There were washout periods of 7 days between treatments.
Sixteen blood samples were collected per participant: at pre-dose and 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 36 hours after administration of each of the study drugs.
The pharmacokinetic parameters and relative bioavailabilities of diclofenac and tramadol (and of the tramadol metabolite M1) were determined for the new fixed-dose combination product and were compared to the single compound reference products.
Furthermore, the safety (frequency of adverse events) and tolerability of the new fixed-dose combination of diclofenac 25 mg and 25 mg tramadol in healthy men and women was assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Longitudinal, prospective, crossover, open, randomized, single-dose study with 3 periods, 2 sequences (ACB and BCA), and 3 treatments (A, B, and C) in healthy participants and under fasting conditions.
| Arm | Type | Receives |
|---|---|---|
| Diclofenac 25 mg | Experimental | Drug: Diclofenac sodium 25 mgParticipants receive 1 tablet of diclofenac sodium 25 mg with 250 milliliters of purified water. |
| Tramadol 25 mg | Experimental | Drug: Tramadol hydrochloride 25 mgParticipants receive 1 tablet of tramadol hydrochloride 25 mg with 250 milliliters of purified water. |
| Diclofenac/Tramadol 25 mg/25 mg FDC | Experimental | Drug: Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mgParticipants receive 1 fixed-dose combination tablet of diclofenac sodium 25 mg/tramadol hydrochloride 25 mg with 250 milliliters of purified water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Man or woman between 18 and 55 years of age.
- Women with use of a barrier method as a contraceptive.
- Body mass index equal to or above 18.0 and equal to or less than 27.0 kilograms per square meter.
- Clinically healthy. If the clinical history, the registration of vital signs and the physical examination did not show abnormal deviations that avoid their participation in a clinical study.
- Without a history of allergic reactions to the study drug.
Key exclusion criteria (14 listed)
- Findings in the clinical history, vital signs and/or physical examination that show abnormal conditions of the general state of health of the participant that avoid its participation in a clinical study.
- Recent exposure to the study drug between the 30 days prior or any other medication by prescription or self consumed between the 14 days prior to the start of the study, or that do not accept to avoid its consumption during the course of the study.
- Surgery during the 30 days prior to the start of the study.
- Suspicion or evidence of infection by Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
- Serologic test for syphilis (Venereal Disease Research Laboratory test) positive.
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 |
|---|---|---|
| Diclofenac sodium 25 mgDiclofenac sodium 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador) | Drug | Diclofenac 25 mg |
| Tramadol hydrochloride 25 mgTramadol hydrochloride 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador) | Drug | Tramadol 25 mg |
| Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mgAlso: Adorlan (Trade Mark)Fixed-dose combination tablet containing diclofenac sodium 25 mg and tramadol hydrochloride 25 mg (Laboratorios Tecnandina S.A., Ecuador) | Drug | Diclofenac/Tramadol 25 mg/25 mg FDC |
Primary outcome
Maximum plasma concentration (Cmax) of diclofenac
Time frame: From pre-dose to 36 hours post-dose
16 plasma samples were collected from pre-dose to 36 hours post-dose. Diclofenac concentrations were determined using validated analytical methods.
Maximum plasma concentration (Cmax) of tramadol
Time frame: From pre-dose to 36 hours post-dose
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol concentrations were determined using validated analytical methods.
Area under the plasma concentration curve from the administration until the time t (AUC0-t) of diclofenac
Time frame: From pre-dose to 36 hours post-dose
16 plasma samples were collected from pre-dose to 36 hours post-dose. Diclofenac concentrations were determined using validated analytical methods.
Area under the plasma concentration curve from the administration until the time t (AUC0-t) of tramadol
Time frame: From pre-dose to 36 hours post-dose
16 plasma samples were collected from pre-dose to 36 hours post-dose. Tramadol concentrations were determined using validated analytical methods.
14 secondary outcomes
Maximum plasma concentration (Cmax) of tramadol metabolite M1
Time frame: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from the administration until the time t (AUC0-t) of tramadol metabolite M1
Time frame: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from 0 to infinity (AUC0-inf) of tramadol
Time frame: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from 0 to infinity (AUC0-inf) of tramadol metabolite M1
Time frame: From pre-dose to 36 hours post-dose
Area under the plasma concentration curve from 0 to infinity (AUC0-inf) of diclofenac
Time frame: From pre-dose to 36 hours post-dose
Time to maximum plasma concentration (Tmax) for tramadol
Time frame: From pre-dose to 36 hours post-dose
Time to maximum plasma concentration (Tmax) for tramadol metabolite M1
Time frame: From pre-dose to 36 hours post-dose
Time to maximum plasma concentration (Tmax) for diclofenac
Time frame: From pre-dose to 36 hours post-dose
Elimination half life (t half) for tramadol
Time frame: From pre-dose to 36 hours post-dose
Elimination half life (t half) for tramadol metabolite M1
Time frame: From pre-dose to 36 hours post-dose
Elimination half life (t half) for diclofenac
Time frame: From pre-dose to 36 hours post-dose
Elimination rate constant (KE) for tramadol
Time frame: From pre-dose to 36 hours post-dose
Elimination rate constant (KE) for tramadol metabolite M1
Time frame: From pre-dose to 36 hours post-dose
Elimination rate constant (KE) for diclofenac
Time frame: From pre-dose to 36 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 11 Dec 2018.
- Individual participant dataSharing planned: Yes. Information available on the Grünenthal Web Site (see URL below for details)
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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.
Grünenthal Study Director study director
Grünenthal GmbH
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 Diclofenac sodium 25 mg, Tramadol hydrochloride 25 mg and Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg in people with Pharmacokinetics, run by Grünenthal GmbH at 1 site in Mexico.
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 10 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 11 Dec 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 Mexico. 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?
Maximum plasma concentration (Cmax) of diclofenac (time frame: From pre-dose to 36 hours post-dose). The study lists 4 primary outcomes in all. 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 11 Dec 2018.