Benign Prostatic Hyperplasia (BPH)Phase 1NCT01829893
PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination
A Phase 1 study testing In combination of 0.2mg finasteride and 5mg tamsulosin and GL2701 capsule in people with Benign Prostatic Hyperplasia (BPH), run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
To compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study. 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
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- In combination of 0.2mg finasteride and 5mg tamsulosin and GL2701 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Feb 2012
- 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
- Males age 20 to 45 years
- Body weight > 50 kg with 18~29 kg/m2 body mass index (BMI)
- Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations
Who cannot join
- subjects with acute conditions.
- presence of history affecting ADME
- Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
- Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
- Any other acute or chronic disease
- A history of hypersensitivity to donepezil
Show all 15Show fewer
- A history of alcohol or drug abuse
- Participation in another clinical trial within 3 months
- smoked >10 cigarettes daily
- consumption over 5 glasses daily of beverages containing xanthine derivatives
- use of any medication having the potential to affect the study results within 10 days before the start of the study.
- AST or ALT > 1.25 of upper normal limit
- total bilirubin > 1.5 of upper normal limit
- systolic blood pressure < 90 mmHg
- calculated CLcr using Cockroft-Gault equation < 50 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics Between Coadministered Finasteride Tablet and Tamsulosin HCl Tablet and GL2701 Capsule, in Healthy Subjects
To compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.
Read the detailed description
This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects.
For this, a single-center, randomized, single-dose, open-label, 2-period and 2-sequence crossover study with a 14-day washout period was conducted in 26 healthy volunteers. Plasma samples for the analysis of finasteride/tamsulosin were collected up to 48 h after drug administration. Participants received either reference (in combination of of 0.2mg tamsulosin and 5mg finasteride) or test drug formulation (single pill combination of 0.2mg tamsulosin and 5mg finasteride) in the first period and the alternative formulation in the second period. Plasma concentrations of both tamsulosin and finasteride were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI) were calculated. According to regulatory requirements set forth by Korea and the US Food and Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are within the range of 0.80 to 1.25.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- In combination of 0.2mg finasteride and 5mg tamsulosin, GL2701 capsule
- Keywords
- Benign Prostatic Hyperplasia (BPH), pharmacokinetics, bioequivalence, finasteirde, tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In combination of 0.2mg finasteride and 5mg tamsulosinDrug
Also called GL2701 capsule
oral medication with 240 mL water
GL2701 capsuleDrug
Also called Harunal-D (tamsulosin 0.2mg), Prosca (Finasteride 5 mg)
oral medication with 240 mL water
| Study group | Role | What they receive |
|---|---|---|
| Reference arm | Active comparator | Treated with Reference (in combination of 0.2mg tamsulosin and 5mg finasteride) Intervetion: In combination of 0.2mg finasteride and 5mg tamsulosin simultaneously Receives: Drug: In combination of 0.2mg finasteride and 5mg tamsulosin |
| Test arm | Experimental | Treated with Test formulation (single pill combination of 0.2mg finasteride and 5mg tamsulosin) Intervention : GL2701 capsule Receives: Drug: GL2701 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC)
Measured: 48 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GL Pharm Tech Corporation
- Responsible party
- Principal investigator, Ji-Young Park, Korea University Anam Hospital
- Investigators
- Ji-Young Park, MD, PhD, Principal investigator, Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829893
- Sponsor's protocol ID
- GP-FITAM-104
- Status last verified
- Dec 2011
- First submitted
- 8 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized Comparative Study to Evaluate the Pharmacokinetic Characteristics Between Coadministered Finasteride Tablet and Tamsulosin HCl Tablet and GL2701 Capsule, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01829893
- Acronym / sponsor ID
- GP-FITAM-104
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Keywords
- Benign Prostatic Hyperplasia (BPH), pharmacokinetics, bioequivalence, finasteirde, tamsulosin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- GL Pharm Tech Corporation
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Apr 2013 (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.
To compare the relative bioavailability and pharmacokinetic characteristics of a newly single pill combination of finasteride and tamsulosin with a conventional combination of finasteride and tamsulosin in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.
Detailed description
This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects.
For this, a single-center, randomized, single-dose, open-label, 2-period and 2-sequence crossover study with a 14-day washout period was conducted in 26 healthy volunteers. Plasma samples for the analysis of finasteride/tamsulosin were collected up to 48 h after drug administration. Participants received either reference (in combination of of 0.2mg tamsulosin and 5mg finasteride) or test drug formulation (single pill combination of 0.2mg tamsulosin and 5mg finasteride) in the first period and the alternative formulation in the second period. Plasma concentrations of both tamsulosin and finasteride were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI) were calculated. According to regulatory requirements set forth by Korea and the US Food and Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are within the range of 0.80 to 1.25.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference arm | Active comparator | Drug: In combination of 0.2mg finasteride and 5mg tamsulosinTreated with Reference (in combination of 0.2mg tamsulosin and 5mg finasteride) Intervetion: In combination of 0.2mg finasteride and 5mg tamsulosin simultaneously |
| Test arm | Experimental | Drug: GL2701 capsuleTreated with Test formulation (single pill combination of 0.2mg finasteride and 5mg tamsulosin) Intervention : GL2701 capsule |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males age 20 to 45 years
- Body weight > 50 kg with 18~29 kg/m2 body mass index (BMI)
- Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations
Key exclusion criteria (15 listed)
- subjects with acute conditions.
- presence of history affecting ADME
- Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
- Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
- Any other acute or chronic disease
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 |
|---|---|---|
| In combination of 0.2mg finasteride and 5mg tamsulosinAlso: GL2701 capsuleoral medication with 240 mL water | Drug | Reference arm |
| GL2701 capsuleAlso: Harunal-D (tamsulosin 0.2mg), Prosca (Finasteride 5 mg)oral medication with 240 mL water | Drug | Test arm |
Primary outcome
Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC)
Time frame: 48 hr
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 Apr 2013.
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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.
Ji-Young Park, MD, PhD principal investigator
Department of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
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 In combination of 0.2mg finasteride and 5mg tamsulosin and GL2701 capsule in people with Benign Prostatic Hyperplasia (BPH), run by Korea University Anam Hospital 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 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 11 Apr 2013. 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?
Finasteride and Tamsulosin pharmacokinetics (Cmax and AUC) (time frame: 48 hr). 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 Apr 2013.