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The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this study are expected to support registration applications for androgenetic alopecia (AGA) in Japan and other international markets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental | Subjects will be hospitalized to the clinical unit on the evening of Day -1. All subjects will receive 1 x 0.5mg oral dose of dutasteride (Sequence A), in the morning; Subjects will remain in the clinical unit until completion of all assessments at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample. Subjects will return to the unit for the remaining PK samples at 36, 48 and 72 hours. The subject will receive or 5 x 0.1mg oral dose of dutasteride (Sequence B) in similar fashion as that of Sequence A. The two treatment sequences will be separated by a minimum washout period of 28 days to ensure that dutasteride is effectively eliminated from the subject between dosing occasions. |
|
| Sequence BA | Experimental | Subjects will be hospitalized to the clinical unit on the evening of Day -1. All subjects will receive 5 x 0.1mg oral dose of dutasteride (Sequence B) in the morning; Subjects will remain in the clinical unit until completion of all assessments at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample. Subjects will return to the unit for the remaining PK samples at 36, 48 and 72 hours. The subjects will receive 1 x 0.5mg oral dose of dutasteride (Sequence A) in similar fashion as that of Sequence B, The two treatment sequences will be separated by a minimum washout period of 28 days to ensure that dutasteride is effectively eliminated from the subject between dosing occasions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI198745 0.1 mg | Drug | It is available as soft gelatin capsule to be administered as 5 X 0.1 mg capsules as single oral dose with approximately 250 mL of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum pharmacokinetic (PK) parameters: maximum observed concentration (Cmax) and Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC[0-t]) for dutasteride | Serum PK samples will be collected pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours post dose for both treatment periods | From pre-dose up to 72 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cmax (tmax) for dutasteride as data permit | Serum PK samples will be collected pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6 8, 10, 12, 18, 24, 36, 48, and 72 hours post dose for both treatment periods | From pre-dose up to 72 hrs |
| Safety and tolerability of all treatments as assessed by vital signs, electrocardiogram (ECG) measurements, review of adverse events (AEs) and clinical laboratory safety data |
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Inclusion Criteria:
Exclusion Criteria:
An average weekly intake of >21 units for males. In Australia one unit (=standard drink) is equivalent to 10 gram of alcohol: 270 milliliter (mL) of full strength beer (4.8%), 375 mL of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250mL pre-mix full strength spirit (5%), 100 mL of wine (13.5%) and 30 mL of spirit (40%).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Randwick | New South Wales | 2031 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27536459 | Derived | Fossler MJ, Collins DA, Ino H, Sarai N, Ravindranath R, Bowen CL, Burns O. Evaluation of bioequivalence of five 0.1 mg dutasteride capsules compared to one 0.5 mg dutasteride capsule: a randomized study in healthy male volunteers. J Drug Assess. 2015 Jul 14;4(1):24-9. doi: 10.3109/21556660.2015.1067219. eCollection 2015. |
| Label | URL |
|---|---|
| Results for study 117342 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 117342 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| GI198745 0.5 mg | Drug | It is available as soft gelatin capsule to be administered as 1 X 0.5 mg capsules as single oral dose with approximately 250 mL of water. |
|
Vital signs will include pulse rate and blood pressure measurements.12-lead ECGs will be obtained at the planned time point. An AE is any untoward medical occurrence temporally associated with the use of the medicinal product, whether or not considered associated with the product. Clinical laboratory tests will include hematology, clinical chemistry and urinalysis parameters. |
| From screening till Follow-up visit (10-14 days post-last dose)& 50-54 days post-last dose |
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 117342 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117342 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117342 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117342 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117342 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117342 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |