HealthyNCT02660060
Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg
A study testing Pramipexole Dexa Medica and Pramipexole Boehringer Ingelheim Pharma in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
Trial summary
The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pramipexole Dexa Medica and Pramipexole Boehringer Ingelheim Pharma
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIndonesia
- Study dates
- May 2015to Jun 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects
- Preferably non-smokers or smoke less than 10 cigarettes per day
- Body mass index within 18 to 25 kg/m2
- Normal vital signs (after 10 minutes rest): systolic blood pressure 100 - 120 mmHg, diastolic blood pressure 60 - 80 mmHg, pulse rate 60 - 90 bpm
Who cannot join
- Personal / family history of allergy or hypersensitivity or contraindication to pramipexole or allied drugs
- Pregnant or lactating women
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness
- Any clinically significant abnormal values of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 upper limit normal), renal function test (serum creatinine > 1.4 mg/dL), etc
- Positive Hepatitis B surface antigen (HbsAg), anti-HCV, or anti-HIV
- Clinically significant hematology abnormalities
Show all 15Show fewer
- Clinically significant ECG abnormalities
- Any surgical or medical condition (present or history) which might significantly alter the pharmacokinetics of the study drug
- History of anaphylaxis or angioedema
- History of drug or alcohol abuse within 12 months prior to screening
- Participation in any clinical trial within the past 90 days
- History of any bleeding or coagulative disorders
- History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm
- A donation or loss of 300 mL (or more) of blood within 3 months before the study's first dosing day
- Intake of any prescription, non-prescription drug, food supplement or herbal medicine within 14 days of the study's first dosing day
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
PT Equilab International
Jakarta, Jakarta Special Capital Region, 12430
About this study
Official title: Bioequivalence Study of 0.25 mg Pramipexole Tablets Produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in Comparison With the Comparator Product (Sifrol® 0.25 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International, GmbH, Germany)
The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
Read the detailed description
This was a randomized, open label, two-period, two-sequence, crossover study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Pramipexole 0.25 mg produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals) or one tablet of the reference drug (Sifrol® 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug. The plasma concentrations of pramipexole were determined by validated ultra performance liquid chromatography with mass spectrometry detector (UPLC-MS/MS).
- Conditions
- Healthy
- Being tested
- Pramipexole Dexa Medica, Pramipexole Boehringer Ingelheim Pharma
- Keywords
- Pramipexole, Bioequivalence, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole Dexa MedicaDrug
Pramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug.
Pramipexole Boehringer Ingelheim PharmaDrug
Also called Sifrol®
Pramipexole 0.25 tablets produced by Boehringer Ingelheim Pharma GmbH \& Co.KG for Boehringer Ingelheim International GmbH as the reference drug.
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole Dexa Medica | Experimental | Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period. Receives: Drug: Pramipexole Dexa Medica |
| Pramipexole Boehringer Ingelheim Pharma | Active comparator | Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period. Receives: Drug: Pramipexole Boehringer Ingelheim Pharma |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt
Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Measured: 48 hours
AUCinf
Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Measured: 48 hours
Cmax
The peak plasma concentration of the drug was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Measured: 48 hours
Secondary outcomes (2)
Tmax
The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Measured: 48 hours
T1/2
The elimination half life was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionJun 2015
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ratih SI Putri, MD, Principal investigator, PT Equilab International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660060
- Sponsor's protocol ID
- PR.193/EQL/2010
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of 0.25 mg Pramipexole Tablets Produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals in Comparison With the Comparator Product (Sifrol® 0.25 mg Tablet, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany for Boehringer Ingelheim International, GmbH, Germany)
- ClinicalTrials.gov ID
- NCT02660060
- Acronym / sponsor ID
- PR.193/EQL/2010
- Conditions
- Healthy
- Keywords
- Pramipexole, Bioequivalence, Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Jan 2016 (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 present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
Detailed description
This was a randomized, open label, two-period, two-sequence, crossover study under fasting condition. The participating subjects were required to have an overnight fast and in the next morning were given orally one tablet of the test drug (Pramipexole 0.25 mg produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals) or one tablet of the reference drug (Sifrol® 0.25 mg, Boehringer Ingelheim Pharma GmbH \& Co. KG, Germany for Boehringer Ingelheim International GmbH, Germany).
Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the first drug administration (washout period), the procedure was repeated using the alternate drug. The plasma concentrations of pramipexole were determined by validated ultra performance liquid chromatography with mass spectrometry detector (UPLC-MS/MS).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramipexole Dexa Medica | Experimental | Drug: Pramipexole Dexa MedicaEach tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period. |
| Pramipexole Boehringer Ingelheim Pharma | Active comparator | Drug: Pramipexole Boehringer Ingelheim PharmaEach tablet contains 0.25 mg pramipexole dihydrochloride monohydrate. An oral single dose of the tablet was administered at the first day of each treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects
- Preferably non-smokers or smoke less than 10 cigarettes per day
- Body mass index within 18 to 25 kg/m2
- Normal vital signs (after 10 minutes rest): systolic blood pressure 100 - 120 mmHg, diastolic blood pressure 60 - 80 mmHg, pulse rate 60 - 90 bpm
Key exclusion criteria (15 listed)
- Personal / family history of allergy or hypersensitivity or contraindication to pramipexole or allied drugs
- Pregnant or lactating women
- Any major illness in the past 90 days or clinically significant ongoing chronic medical illness
- Any clinically significant abnormal values of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 upper limit normal), renal function test (serum creatinine > 1.4 mg/dL), etc
- Positive Hepatitis B surface antigen (HbsAg), anti-HCV, or anti-HIV
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 |
|---|---|---|
| Pramipexole Dexa MedicaPramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug. | Drug | Pramipexole Dexa Medica |
| Pramipexole Boehringer Ingelheim PharmaAlso: Sifrol®Pramipexole 0.25 tablets produced by Boehringer Ingelheim Pharma GmbH \& Co.KG for Boehringer Ingelheim International GmbH as the reference drug. | Drug | Pramipexole Boehringer Ingelheim Pharma |
Primary outcome
AUCt
Time frame: 48 hours
Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pramipexole from the test drug and reference drug.
AUCinf
Time frame: 48 hours
Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pramipexole from the test drug and reference drug.
Cmax
Time frame: 48 hours
The peak plasma concentration of the drug was determined from plasma concentrations of pramipexole from the test drug and reference drug.
2 secondary outcomes
Tmax
Time frame: 48 hours
T1/2
Time frame: 48 hours
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 21 Jan 2016.
- Individual participant dataSharing planned: No
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.
Ratih SI Putri, MD principal investigator
PT Equilab International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pramipexole Dexa Medica and Pramipexole Boehringer Ingelheim Pharma in people with Healthy, run by Dexa Medica Group at 1 site in Indonesia.
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 15 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 21 Jan 2016. 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 Indonesia. 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?
AUCt (time frame: 48 hours). The study lists 3 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 21 Jan 2016.