# A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia

> **NCT01495026** · PHASE1 · COMPLETED · sponsor: **GlaxoSmithKline** · enrollment: 63 (actual)

## Conditions studied

- Prostatic Hyperplasia

## Interventions

- **DRUG:** Dutasteride (0.5mg, fasted state)
- **DRUG:** Dutasteride (0.5mg, fed state)
- **DRUG:** Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- **DRUG:** Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- **DRUG:** Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- **DRUG:** Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fed state)
- **DRUG:** Harnal-D Tablets with water (fasted state)
- **DRUG:** Harnal-D Tablets with water (fed state)
- **DRUG:** Harnal-D tablets without water (fasted state)

## Key facts

- **NCT ID:** NCT01495026
- **Lead sponsor:** GlaxoSmithKline
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-11-06
- **Primary completion:** 2012-04-03
- **Final completion:** 2012-04-03
- **Target enrollment:** 63 (ACTUAL)
- **Last updated:** 2018-06-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01495026

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01495026, "A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia". Retrieved via AI Analytics 2026-07-03 from https://api.ai-analytics.org/clinical/NCT01495026. Licensed CC0.

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