Clinical trials: Healthy Females
Healthy
Study Comparing Two Manufacturing Processes for Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg (LNG/EE) in Healthy, Cycling Women
Primary Objective: To determine the bioequivalence between the clinical batch process and the new processes for manufacturing LNG/EE.
- Trial name
- NCT00319163
- Testing
- levonorgestrel/ethinyl estradiol
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy Volunteer
Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810
This is a phase 1, randomized, open-label, single center, crossover study to investigate the effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy participants of non-childbearing potential.
- Trial name
- NCT02722018
- Testing
- GDC-0810 Phase II Tablet, GDC-0810 Phase III Prototype Tablet
- Where
- United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Smoking Cessation
Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch
An investigation on the cumulative skin irritation potential of a newly developed 15 mg nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal patch.
- Trial name
- NCT00965913
- Testing
- Nicotine Patch, Nicotine Patch Comparator
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- McNeil AB
Healthy
Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects
To demonstrate that BI 201335 does not prolong the QT interval more than placebo. To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before…
- Trial name
- NCT02182310
- Testing
- BI 201335 low dose, Moxifloxacin, BI 201335 high dose
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study of Nipocalimab in Healthy Male and Female Participants
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of nipocalimab following subcutaneous (SC) administration compared with intravenous (IV) administration in healthy participants.
- Trial name
- NCT04848558
- Testing
- Nipocalimab
- Where
- Netherlands
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Female Sexual Health
A Open-Label, Within-Subject Dose-Escalation Study to Evaluate the Clinical Safety and Pharmacokinetic Profile of a Topical Sildenafil Cream (5% w/w), in Healthy Postmenopausal Women
This is a Phase 1, single center, open-label, within-subject dose-escalation study evaluating the safety and pharmacokinetics of SST-6006 in healthy postmenopausal women.
- Trial name
- NCT02364882
- Testing
- Sildenafil
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Strategic Science & Technologies, LLC
Contraception, Menopause
Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
- Trial name
- NCT02720224
- Testing
- Estetrol
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Estetra
Depression, Depressive State
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
To evaluate the pharmacokinetics of single oral dose of Amitriptyline hydrochloride film-coated tablet 10mg \& 25mg
- Conditions
- Depression, Depressive State, Enuresis
- Trial name
- DWETR (NCT01367080)
- Testing
- DWETR10, DWETR25
- Where
- South Korea
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Dong Wha Pharmaceutical Co. Ltd.
Healthy
Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension
To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with varying degrees of renal impairment
- Trial name
- NCT00637403
- Testing
- Megestrol acetate concentrated suspension 125 mg/mL
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Osteoporosis
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout…
- Trial name
- NCT00846196
- Testing
- risedronate DR (Phase III clinical supply), risedronate 35 mg DR (Commercial Tablet)
- Where
- 6 sites in United States
- Volunteers
- 538 people, healthy volunteers welcome
- Sponsor
- Warner Chilcott
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).
- Trial name
- NCT02251756
- Testing
- Actinica, 0.8 mg/cm2, 1 application, Actinica, 0.8 mg/cm2, 2 applications, Actinica, 2 mg/cm2, 1 application
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Healthy Adult Male, Healthy Adult Females
Examining Olive Oil Extract on Knee Comfort and Function
The goal of this study is to learn if an olive oil extract works to improve knee pain and discomfort in adults. The main questions it aims to answer are: 1) Does the olive oil extract improve the perceptions of knee pain and…
- Conditions
- Healthy Adult Male, Healthy Adult Females, Joint Discomfort
- Trial name
- NCT07514013
- Testing
- Olive Oil Extract
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Applied Food Sciences Inc.
Type 2 Diabetes, Diabetes Mellitus, Type 2
Comparative Bioavailability - Gender Effect - Single and Multiple Ascending Dose Safety and Pharmacokinetic Study of GFT505
The Sponsor, Genfit, has developed a new formulation of GFT505 (60 mg). The objective is to compare the relative bioavailability between the new GFT505 formulation (capsule dosed at 60 mg GFT505) and the old GFT505 formulation…
- Conditions
- Type 2 Diabetes, Diabetes Mellitus, Type 2, Metabolic Diseases, Cardiovascular Diseases
- Trial name
- NCT01474161
- Testing
- GFT505 120mg - old formulation, GFT505 120mg - new formulation, GFT505 180mg - new formulation
- Where
- France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Genfit
Clinical Pharmacology
Study on the Safety of BAY 63-2521, How it is Tolerated and the Way the Body Absorbs, Distributes and Gets Rid of the Study Drug Given as a Single Oral Dose of 1 mg Tablet in Participants With Impaired Liver Function and Healthy Participants Matched for Age-, Gender-, and Weight
BAY 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. Renal impairment is a common condition in patients with this disease.
- Trial name
- NCT04366622
- Testing
- Riociguat (Adempas, BAY 63-2521)
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Blister, Wound of Skin
Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.
This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25.
- Conditions
- Blister, Wound of Skin, Epidermolysis Bullosa, Varicose Ulcer of Lower Limb
- Trial name
- NCT05378997
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Xinnate AB
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
The primary purpose of this study is to evaluate the plasma PK of JMKX003142 following a single dose in participants with mild and moderate hepatic impairment compared to matched healthy participants with normal hepatic function.
- Trial name
- NCT07909070
- Testing
- JMKX003142
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jemincare
Renal Impairment
Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD6234
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of single subcutaneous dose of AZD6234 with end stage renal disease, severe, and possibly moderate and mild renal impairment in comparison to a matched…
- Trial name
- NCT06845813
- Testing
- AZD6234
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Bioavailability Study of Donepezil Hydrochloride Tablets 23 mg Under Fed Condition
To evaluate and compare the relative bioavailability and therefore the bioequivalence of two different formulations of donepezil after a single oral dose administration under fed conditions.
- Trial name
- NCT01923259
- Testing
- Donepezil
- Where
- Canada
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Pilot Bioavailability Study of 3 Test Tablet Formulations of Bazedoxifene Compared With A Reference Tablet Formulation of Bazedoxifene/Conjugated Estrogens in Healthy Postmenopausal Women
The purpose of this study is to evaluate 3 test formulations relative to a reference formulation.
- Trial name
- NCT01634789
- Testing
- bazedoxifene, bazedoxifene/conjugated estrogens
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Pfizer
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