Erectile DysfunctionPhase 1NCT01514903
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
A Phase 1 study testing HIP0908 and viagra in people with Erectile Dysfunction, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- HIP0908 and viagra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Dec 2011
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 20 and 45
- weight : over 55kg and 18.5 < BMI, 25.0
- have to give their consent to participating clinical trial by oneself
Who cannot join
- has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc > 430ms or uncontrolled arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.
- Conditions
- Erectile Dysfunction
- Being tested
- HIP0908, viagra
- Keywords
- anti erectile dysfunction agent
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP0908Drug
SINGLE DOSE , CROSS OVER
viagraDrug
single dose, cross over
| Study group | Role | What they receive |
|---|---|---|
| viagra,anti-erectile dysfunction agent | Active comparator | Not described Receives: Drug: viagra |
| HIP0908 | Experimental | Not described Receives: Drug: HIP0908 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC and Cmax of sildenafil
Measured: Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514903
- Sponsor's protocol ID
- HM-SIL-102
- Status last verified
- Oct 2016
- First submitted
- 18 Jan 2012
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01514903
- Acronym / sponsor ID
- HM-SIL-102
- Conditions
- Erectile Dysfunction
- Keywords
- anti erectile dysfunction agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jan 2012 (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.
This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| viagra,anti-erectile dysfunction agent | Active comparator | Drug: viagra |
| HIP0908 | Experimental | Drug: HIP0908 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 20 and 45
- weight : over 55kg and 18.5 < BMI, 25.0
- have to give their consent to participating clinical trial by oneself
Key exclusion criteria (1 listed)
- has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc > 430ms or uncontrolled arrhythmia
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 |
|---|---|---|
| HIP0908SINGLE DOSE , CROSS OVER | Drug | HIP0908 |
| viagrasingle dose, cross over | Drug | viagra,anti-erectile dysfunction agent |
Primary outcome
AUC and Cmax of sildenafil
Time frame: Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr 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 12 Oct 2016.
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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 HIP0908 and viagra in people with Erectile Dysfunction, run by Hanmi Pharmaceutical Company Limited 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 12 Oct 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 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?
AUC and Cmax of sildenafil (time frame: Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose). 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 12 Oct 2016.