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| Name | Class |
|---|---|
| Symyoo | INDUSTRY |
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The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the effects after single oral administration in Korean healthy male volunteers.
Clomipramine is a dibenzazepine-derivative tricyclic antidepressant (TCA) and is a potent inhibitor of serotonin and norepinephrine reuptake. Clomipramine may be used in a variety of indications. Condencia Tab contains low dose of 15mg of clomipramine HCl as an active ingredient, which is newly approved to market for the treatment of premature ejaculation.
This study is a prospective, randomised, open-labeled, 6-sequence, 3-period, 3-treatment, crossover, and single-center clinical trial. A total of 30 healthy male volunteers will be enrolled and randomised into one among 6 groups (5 subjects per a group). The safety and PK/PD characteristics of co-administration of Clomipramine HCl and Sildenafil citrate will be investigated closely compared to the effects after single dose administrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Treatment 1 - Treatment 2 - Treatment 3 |
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| Sequence B | Experimental | Treatment 1 - Treatment 3 - Treatment 2 |
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| Sequence C | Experimental | Treatment 2 - Treatment 1 - Treatment 3 |
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| Sequence D | Experimental | Treatment 2 - Treatment 3 - Treatment 1 |
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| Sequence E | Experimental | Treatment 3 - Treatment 1 - Treatment 2 |
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| Sequence F | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment 1 | Drug | An oral single dose administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The systemic exposure measured as area under the curve (AUC) | From Day 1(dosing) to Day 4(72hrs) | |
| The maximum concentration (Cmax) | From Day 1(dosing) to Day 4(72hrs) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters except the primary endpoints | Including Tmax, T1/2, AUCnorm, Cmax norm, CL/f and Cmax/AUC | From Day 1(dosng) to Day 4(72hrs) |
| The maximum change of systolic blood pressures within 12hrs after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Hi Kang, M.D. | Yangji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangji Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002997 | Clomipramine |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Treatment 3 - Treatment 2 - Treatment 1 |
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| Treatment 2 | Drug | An oral single dose administration |
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| Treatment 3 | Drug | Co-administration of oral single doses |
|
|
At supine and upright positions
| Day 1(dosing) to Day 2(12hrs) |
| Adverse events | For 3 Weeks after dosing |
| The maximum change of dystolic blood pressure within 12hrs after dosing | at supine and upright positions | From Day 1(dosing) to Day 2(12hrs) |
| The maximum change of heart rates within 12 hours after dosing | At supine and upright positions | From Day 1(dosing) to Day 2(12hrs) |
| The rate of the subjects who experienced the clinically significant change of blood pressures | Clinically significant changes will be classified into 4 groups: SBP change >=30 or 20 mmHg, DBP change >= 20 or 10 mmHg (at supine and upright positions) | From Day 1(dosing) to Days 2(12hrs) |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |