Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets

NCT06289881 | Not Yet Recruiting Phase 1

• 1 other identifier: SIL-026-21
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 3 days washout period between the doses.

Conditions

Healthy Subjects

Keywords

Bioequivalence Sildenafil 100 mg tablets

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t)

  pre-dose (0.00 hour) and at 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00 and 24.00 hour post-dose

  Blood samples will be collected for PK analyses in each period pre-dose and at 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00 and 24.00 hour post-dose

• Maximal measured plasma concentration (Cmax)

  pre-dose (0.00 hour) and at 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00 and 24.00 hour post-dose

  Blood samples will be collected for PK analyses in each period pre-dose and at 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00 and 24.00 hour post-dose

Secondary Outcomes (1)

• Number of subjects with adverse events

  Approximately the day 14 after the last visit

Study Arms (2)

Experimental: Sequence 1-Sildenafil test product and then reference product

EXPERIMENTAL

Participants will receive treatment 1 in period 1 and treatment 2 in period 2. Where treatment 1= Sildenafil 100 mg tablets test product, treatment 2= Nebivolol tablets 5 mg reference product.

Drug: Sildenafill-Test product

Experimental: Sequence 2-Sildenafil reference product and then test product

EXPERIMENTAL

Participants will receive treatment 2 in period 1 and treatment 1 in period 2. Where treatment 1= Sildenafil 100 mg tablets test product, treatment 2= Nebivolol tablets 5 mg reference product.

Drug: Sildenafill-Reference product

Interventions

Sildenafill-Test product DRUG

Test-Product: Sildenafil 100 mg tablets Manufactured by: Actigen Co., Ltd., Thailand

Experimental: Sequence 1-Sildenafil test product and then reference product

Sildenafill-Reference product DRUG

Reference-product: Viagra 100 mg tablets Manufactured by: FAREVA AMBOISE, France

Experimental: Sequence 2-Sildenafil reference product and then test product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willingness to provide written informed consent prior to participate in the study.
• Healthy Thai male subjects are between 18 to 55 years of age.
• The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
• Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects' safety after the completion of the study.
• Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician

You may not qualify if:

• History or evidence of allergy or hypersensitivity to Sildenafil any related drugs or any of the excipients of this product.
• Subject with B.P. is Systolic B.P \< 100, ≥140 mm/Hg, Diastolic B.P \< 70, ≥90 mm/Hg or pulse rate \> 100 beats per minute. For study periods, BP evaluation criteria for AE will be \< 90, ≥140 mm/Hg, Diastolic B.P \< 60, ≥90 mm/Hg.
• Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).\*
• Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).\*
• Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).\*
• Positive of hepatitis B or C virus or HIV.
• Have more than one abnormal EKG, which is considered as clinically significant. \*
• History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma, sickle cell anemia, multiple myeloma, or leukemia.
• History of a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
• History of cardiac failure or coronary artery disease causing unstable angina.
• History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
• Any major illness in the past 3 months or any significant ongoing chronic medical illness.
• History of psychiatric disorder.
• History or presence of major active bleeding or abnormal bleeding due to hemorrhoids, epistaxis, gastrointestinal ulcer or other symptoms in past 1 month before the study drug administration and until the completion of the study.
• History of regular alcohol consumption exceeding 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.

Sponsors & Collaborators

• Bio-innova Co., Ltd: lead

Central Study Contacts

Sasitorn Kittivoravitkul, Ph.D.

CONTACT

022549008; sasitorn_k@bio-innova.com

Somkiat Tatritorn, M.D.

CONTACT

022549008; somkiat_t@bio-innova.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: February 4, 2025
• Primary Completion: March 11, 2025
• Study Completion: March 25, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share