HealthyPhase 1NCT03574285
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
A Phase 1 study testing Anpl-one SR Tab. 300mg and Sarpodipil SR Tab. 300mg in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Anpl-one SR Tab. 300mg and Sarpodipil SR Tab. 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2018to 12 Oct 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, non-smoking, male and female subjects, 19 years of age or older
- BMI ≥ 18.0 and ≤ 30.0 kg/m2.
- Females who participate in this study will be of childbearing or non-childbearing potential
Who cannot join
- Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
Trial locations and contacts
1 site in 1 country.
About this study
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
Read the detailed description
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy Thai volunteers under feeding condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
- Conditions
- Healthy
- Being tested
- Anpl-one SR Tab. 300mg, Sarpodipil SR Tab. 300mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anpl-one SR Tab. 300mgDrug
Also called Sarpogrelate HCl 300mg
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Sarpodipil SR Tab. 300mgDrug
Also called Sarpogrelate HCl 300mg
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Anpl-one SR Tab. 300mg | Experimental | Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets Receives: Drug: Anpl-one SR Tab. 300mg; Drug: Sarpodipil SR Tab. 300mg |
| Sarpodipil SR Tab. 300mg | Active comparator | Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets Receives: Drug: Anpl-one SR Tab. 300mg; Drug: Sarpodipil SR Tab. 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration
Cmax
Measured: 0-24hr
Area under the plasma concentration versus time curve
AUC
Measured: 0-24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start31 May 2018
- Primary completion21 Aug 2018
- Study completion12 Oct 2018
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574285
- Sponsor's protocol ID
- DDS17-035BE
- Status last verified
- May 2019
- First submitted
- 20 Jun 2018
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
- ClinicalTrials.gov ID
- NCT03574285
- Acronym / sponsor ID
- DDS17-035BE
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 31 May 2018 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 12 Oct 2018 (actual)
- First posted
- 29 Jun 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.
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
Detailed description
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy Thai volunteers under feeding condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anpl-one SR Tab. 300mg | Experimental | Drug: Anpl-one SR Tab. 300mg, Drug: Sarpodipil SR Tab. 300mgAnpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets |
| Sarpodipil SR Tab. 300mg | Active comparator | Drug: Anpl-one SR Tab. 300mg, Drug: Sarpodipil SR Tab. 300mgSarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy, non-smoking, male and female subjects, 19 years of age or older
- BMI ≥ 18.0 and ≤ 30.0 kg/m2.
- Females who participate in this study will be of childbearing or non-childbearing potential
Key exclusion criteria (1 listed)
- Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
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 |
|---|---|---|
| Anpl-one SR Tab. 300mgAlso: Sarpogrelate HCl 300mgAnpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets | Drug | Anpl-one SR Tab. 300mg, Sarpodipil SR Tab. 300mg |
| Sarpodipil SR Tab. 300mgAlso: Sarpogrelate HCl 300mgSarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets | Drug | Anpl-one SR Tab. 300mg, Sarpodipil SR Tab. 300mg |
Primary outcome
Maximum Plasma Concentration
Time frame: 0-24hr
Cmax
Area under the plasma concentration versus time curve
Time frame: 0-24hr
AUC
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 May 2019.
- Individual participant dataSharing planned: No
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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.
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 Anpl-one SR Tab. 300mg and Sarpodipil SR Tab. 300mg in people with Healthy, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 3 inclusion and 1 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 May 2019. 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 South Korea. 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 (time frame: 0-24hr). The study lists 2 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 13 May 2019.