HealthyNCT02233777
Bioequivalence Study of Two Formulations of Pregabalin Capsules 150 mg
A study testing Pregabalin capsules 150 mg of Dexa Medica and Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland 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 150 mg pregabalin capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany). 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?
- Pregabalin capsules 150 mg of Dexa Medica and Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- Jun 2014to Jun 2014
- 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
- Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history, or physical examination during the screening and could be considered healthy based on the evaluation
- Aged 18-55 years inclusive
- Preferably non-smokers or smoke less than 10 cigarettes per day
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study
- Body mass index within 18 to 25 kg/m2
- Vital signs (after 10 minutes rest) within the following ranges:
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- 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 pregabalin or allied drugs
- Pregnant or lactating women (urinary pregnancy test was applied to women subjects at screening and before taking the study drug)
- Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness e.g. congestive cardiac failure (heart failure), hepatitis, hypotensive episodes, hyperglycemia, etc
- Presence of any clinically significant abnormal values during screening, e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 ULN), renal function test (serum creatinine concentration > 1.4 mg/dL), etc
- Positive hepatitis B surface antigen (HBsAg), anti-HCV, or anti-HIV
- Clinically significant electrocardiogram (ECG) abnormalities
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- Any surgical or medical condition (present or history) which might significantly alter the absorption, distribution, metabolism, or excretion of the study drug, e.g. gastrointestinal disease including gastric or duodenal ulcers or history of gastric surgery
- Past history of anaphylaxis or angiodema
- History of drug or alcohol abuse within 12 months prior to screening for this study
- Participation in any clinical trial within the past 90 days calculated from the last visit
- History of any bleeding or coagulative disorders
- History of seizure, epilepsy, or any kind of neurological 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 this study's first dosing day
- Intake of any prescription, non-prescription drug, food supplements, or herbal medicines within 14 days of this 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 150 mg Pregabalin Capsules Produced by PT Dexa Medica in Comparison With the Comparator Product (Lyrica® Capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany)
The present study was conducted to find out whether the bioavailability of 150 mg pregabalin capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule 150 mg, Pfizer Manufacturing Deutschland 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 capsule of the test drug (Pregabalin 150 mg produced by Dexa Medica) or one capsule of the reference drug (Lyrica® 150 mg, Pfizer Manufacturing Deutschland 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, 9, 12, 24, 36 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 pregabalin were determined by using validated liquid chromatography with tandem mass spectrometry detection (LC-MS/MS) method.
- Conditions
- Healthy
- Being tested
- Pregabalin capsules 150 mg of Dexa Medica, Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland
- Keywords
- Pregabalin, Bioequivalence, Bioavailability, Pharmacokinetic, Antiepileptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin capsules 150 mg of Dexa MedicaDrug
Also called Test product: pregabalin capsules 150 mg of Dexa Medica
Each capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Pregabalin capsules 150 mg of Pfizer Manufacturing DeutschlandDrug
Also called Reference product: Lyrica® 150 mg, produced by Pfizer Manufacturing Deutschland GmbH, Germany
Each capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin capsules 150 mg of Dexa Medica | Experimental | Each capsule contains 150 mg pregabalin. Receives: Drug: Pregabalin capsules 150 mg of Dexa Medica |
| Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland | Active comparator | Each capsule contains 150 mg pregabalin. Receives: Drug: Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland |
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 pregabalin from the test drug and reference drug.
Measured: 36 hours
AUCinf
Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Measured: 36 hours
Cmax
The peak plasma concentration of the drug was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Measured: 36 hours
Tmax
The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Measured: 36 hours
Secondary outcomes (1)
T1/2
The elimination half life was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 2014
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT02233777
- Sponsor's protocol ID
- BE.293/EQL/2013
- Status last verified
- Sep 2014
- First submitted
- 4 Sep 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of 150 mg Pregabalin Capsules Produced by PT Dexa Medica in Comparison With the Comparator Product (Lyrica® Capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany)
- ClinicalTrials.gov ID
- NCT02233777
- Acronym / sponsor ID
- BE.293/EQL/2013
- Conditions
- Healthy
- Keywords
- Pregabalin, Bioequivalence, Bioavailability, Pharmacokinetic, Antiepileptic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Sep 2014 (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 150 mg pregabalin capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule 150 mg, Pfizer Manufacturing Deutschland 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 capsule of the test drug (Pregabalin 150 mg produced by Dexa Medica) or one capsule of the reference drug (Lyrica® 150 mg, Pfizer Manufacturing Deutschland 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, 9, 12, 24, 36 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 pregabalin were determined by using validated liquid chromatography with tandem mass spectrometry detection (LC-MS/MS) method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin capsules 150 mg of Dexa Medica | Experimental | Drug: Pregabalin capsules 150 mg of Dexa MedicaEach capsule contains 150 mg pregabalin. |
| Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland | Active comparator | Drug: Pregabalin capsules 150 mg of Pfizer Manufacturing DeutschlandEach capsule contains 150 mg pregabalin. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male and female subjects with absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history, or physical examination during the screening and could be considered healthy based on the evaluation
- Aged 18-55 years inclusive
- Preferably non-smokers or smoke less than 10 cigarettes per day
- Able to participate, communicate well with the investigators and willing to provide written informed consent to participate in the study
- Body mass index within 18 to 25 kg/m2
Key exclusion criteria (15 listed)
- Personal/family history of allergy or hypersensitivity or contraindication to pregabalin or allied drugs
- Pregnant or lactating women (urinary pregnancy test was applied to women subjects at screening and before taking the study drug)
- Any major illnesses in the past 90 days or clinically significant ongoing chronic medical illness e.g. congestive cardiac failure (heart failure), hepatitis, hypotensive episodes, hyperglycemia, etc
- Presence of any clinically significant abnormal values during screening, e.g. significant abnormality of liver function test (ALT, alkaline phosphatase, total bilirubin >= 1.5 ULN), renal function test (serum creatinine concentration > 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 |
|---|---|---|
| Pregabalin capsules 150 mg of Dexa MedicaAlso: Test product: pregabalin capsules 150 mg of Dexa MedicaEach capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study. | Drug | Pregabalin capsules 150 mg of Dexa Medica |
| Pregabalin capsules 150 mg of Pfizer Manufacturing DeutschlandAlso: Reference product: Lyrica® 150 mg, produced by Pfizer Manufacturing Deutschland GmbH, GermanyEach capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study. | Drug | Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland |
Primary outcome
AUCt
Time frame: 36 hours
Area under plasma concentration time curve from time zero to the last observed quantifiable concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.
AUCinf
Time frame: 36 hours
Area under plasma concentration time curve from time zero to infinity was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Cmax
Time frame: 36 hours
The peak plasma concentration of the drug was determined from plasma concentrations of pregabalin from the test drug and reference drug.
Tmax
Time frame: 36 hours
The time needed to achieve the peak plasma concentration was determined from plasma concentrations of pregabalin from the test drug and reference drug.
1 secondary outcome
T1/2
Time frame: 36 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 8 Sep 2014.
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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.
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 Pregabalin capsules 150 mg of Dexa Medica and Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland 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 9 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 8 Sep 2014. 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: 36 hours). 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 8 Sep 2014.