- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509104
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
June 18, 2018 updated by: GlaxoSmithKline
An Open-label, Randomized, Single Dose, Two-way Crossover Study to Determine the Bioavailability of One Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of One Dutasteride 0.5 mg Capsule and One Tamsulosin Hydrochloride 0.2 mg Tablet in Healthy Male Subjects in the Fed and Fasted States
The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2
mg) relative to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in healthy male subjects in fed and fasted states.
This is an open-label, randomized, single dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1) and fed (Cohort 2) conditions.
In both cohorts, one FDC capsule formulation of dutasteride 0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period.
Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive treatment under fasted or fed conditions) and will participate in both treatment periods.
The two treatment periods will be separated by a minimum washout period of 28 days.
The total duration in the study for each subject will be approximately 2.5 months from screening to the final follow-up visit.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21225
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male subjects aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 50 kilogram (kg) and body mass index (BMI) within the range 18 to 30 kg per meter square (m^2) (inclusive).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion Criteria:
- Alanine aminotransferase (ALT) and bilirubin >1.5xUpper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
- History of diabetes or peptic ulcer disease which is uncontrolled by medical management.
- Current or history of: Breast cancer or clinical breast examination finding suggestive of breast malignancy; Malignancy within the past five years, except for basal cell carcinoma of the skin. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
- Prior medical history or evidence of prostate cancer (e.g., positive biopsy, or suspicious ultrasound, or suspicious digital rectal examination [DRE]). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable prostate specific antigen (PSA) are eligible for the study.
- Based on averaged corrected QT (QTc) values of triplicate ECGs obtained over a brief recording period: QTcF > 450 millisecond (msec).
- Subjects must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the Study.
- History of regular alcohol consumption within 6 months of the study defined as: For United States sites: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 millilitre [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL over the duration of the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 50 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Unable to swallow and retain oral medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 Fasted condition
Each subject will receive both treatments A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods.
Subjects will receive the study treatments under fasting conditions.
|
Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule.
Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet.
Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule.
Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex.
|
Experimental: Cohort 2 Fed condition
Each subject will receive both treatment A and B in either of period 1 or 2 with a washout period of 28 days between treatment periods.
Subjects will receive the study treatments under fed (high fat breakfast) conditions.
|
Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule.
Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet.
Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule.
Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin
Time Frame: Days 1 to 4 of both treatment periods
|
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 hours post dose in both the treatment periods.
Cmax will be determined for tamsulosin and dutasteride.
|
Days 1 to 4 of both treatment periods
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Area under the serum concentration-time curve (AUC) zero to time 't' (AUC[0-t]) for tamsulosin and dutasteride; AUC 0 to infinity (AUC 0-inf) will be determined for tamsulosin as data permit
Time Frame: Days 1 to 4 of both treatment periods
|
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 hours post dose in both the treatment periods.
AUC 0-t will be determined for tamsulosin and dutasteride.
Additionally, AUC 0-inf will be determined for tamsulosin as data permit.
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Days 1 to 4 of both treatment periods
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of occurrence of Cmax (Tmax) for dutasteride and tamsulosin
Time Frame: Days 1 to 4 of both treatment periods
|
Blood samples for PK analysis will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 hours post dose in both the treatment periods.
Tmax will be determined for tamsulosin and dutasteride.
|
Days 1 to 4 of both treatment periods
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Terminal phase half-life (t1/2) for tamsulosin
Time Frame: Days 1 to 4 of both treatment periods
|
Blood samples for PK analysis of tamsulosin and dutasteride will be collected for each subject at the following time points: Pre-dose, 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48 & 72 h post dose in both the treatment periods.
Terminal phase half-life will be determined for tamsulosin.
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Days 1 to 4 of both treatment periods
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Number of participants with adverse events (AE) /serious adverse event (SAE) as a measure of safety and tolerability
Time Frame: From start of study treatment until follow-up contact (up to Week 7)
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AEs and SAEs will be collected from the start of study Treatment until the follow-up contact.
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From start of study treatment until follow-up contact (up to Week 7)
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Composite of vital signs as a measure of safety and tolerability
Time Frame: Screening visit, Day -1, and Day 2 (in both treatment periods) and follow-up visit (up to 2.5 months).
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Vital signs will be measured in semi-supine position after 5 minutes rest and will include temperature, systolic and diastolic blood pressure and pulse rate.
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Screening visit, Day -1, and Day 2 (in both treatment periods) and follow-up visit (up to 2.5 months).
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Composite of 12-lead electrocardiogram (ECG) assessment as a safety measure
Time Frame: Screening, Day 1 and Day 2 in both treatment periods and follow-up visit (up to 2.5 months).
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ECG measurement include heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals.
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Screening, Day 1 and Day 2 in both treatment periods and follow-up visit (up to 2.5 months).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 30, 2015
Primary Completion (Actual)
October 10, 2015
Study Completion (Actual)
October 10, 2015
Study Registration Dates
First Submitted
July 23, 2015
First Submitted That Met QC Criteria
July 23, 2015
First Posted (Estimate)
July 27, 2015
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 18, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- 5-alpha Reductase Inhibitors
- Tamsulosin
- Dutasteride
Other Study ID Numbers
- 201897
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Clinical Study Report
Information identifier: 201897Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 201897Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 201897Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 201897Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 201897Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 201897Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 201897Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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