Clinical trials: Pharmaceutical Preparations
Healthy
Bioequivalence Study of Daclatasvir From Prodactariv 60 mg Film Coated Tablets (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and Clatazev 60 mg Tablets (Bristol-Myers Squibb Pharma, UK)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Daclatasvir from Prodactariv 60 mg F.C.T (International Drug Agency for Pharmaceutical Industry (IDI), Egypt) and…
- Trial name
- NCT02780362
- Testing
- Prodactariv, Clatazev
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Bioequivalence, Healthy Subjects
Bioequivalence Study of 8 mg Perindopril Tert-butylamine / 2.5 mg Indapamide Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC…
- Trial name
- NCT05464745
- Testing
- PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets, Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets
- Where
- Jordan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Healthy
A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants
The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other…
- Trial name
- NCT05028673
- Testing
- Lu AG06466 Capsule, Lu AG06466 Tablet, Antacid
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Seizures
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including…
- Trial name
- NCT02318602
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- INSYS Therapeutics Inc
Healthy
Bioequivalence Study of Favipiravir From Flupirava 200 mg Tablet (European Egyptian Pharmaceutical Industries , Egypt) Versus Avigan 200 mg Tablets (Man. by Toyama Chemical Co., Ltd Japan)
An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Favipiravir from Flupirava 200 mg tablet (European Egyptian Pharmaceutical Industries, Egypt) versus Avigan 200 mg…
- Trial name
- NCT04478448
- Testing
- Flupirava, Avigan
- Where
- Egypt
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Renal Transplantation
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept relative to Process C belatacept in Healthy subjects
- Trial name
- NCT02564497
- Testing
- Process E Belatacept, Process C Belatacept
- Where
- United States
- Volunteers
- 491 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Sunburn
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms
Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil…
- Trial name
- NCT01237925
- Testing
- Dexchlorpheniramine 1% gel, Dexchlorpheniramine 1% cream
- Where
- Brazil
- Volunteers
- 124 people
- Sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
Cystic Fibrosis, Chronic Pancreatitis
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis…
- Trial name
- NCT05069597
- Testing
- CREON
- Where
- 21 sites in United States
- Volunteers
- 30 people
- Sponsor
- AbbVie
Healthy
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.
- Trial name
- NCT01928069
- Testing
- Torrent's Montelukast Sodium Tablets 10 mg
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single…
- Trial name
- NCT01069913
- Testing
- BG00012
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Clopidogrel Tablets Under Fasting Conditions
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Clopidogrel Tablets USP 1 × 75 mg and Plavix® (Clopidogrel Bisulfate) Tablets 1 × 75 mg of Bristol-Myers Squibb/Sanofi…
- Trial name
- NCT01630642
- Testing
- Torrent's Clopidogrel Tablets USP 75 mg
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Depression
Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment
This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.
- Trial name
- NCT02523105
- Testing
- EEG monitoring
- Where
- 2 sites in Israel
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Brainmarc Ltd.
Arterial Hypertension
Efficacy and Safety Evaluating Study to Compare Kanarb (Fimasartan) and Cozaar® (Losartan) in Adult Patients With Grade I-II Arterial Hypertension
Assess and compare the efficacy and safety of Kanarb (Fimasartan), manufactured by Boryung Pharmaceutical Co., Ltd, Republic of Korea, tablets 60/120 mg and Cozaar® (Losartan), manufactured by MERCK SHARP \& DOHME B.V.…
- Trial name
- NCT02248961
- Testing
- Fimasartan, Losartan
- Where
- 13 sites in Russia
- Volunteers
- 179 people
- Sponsor
- R-Pharm
Healthy Subjects
Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.
Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA.
- Trial name
- NCT02962310
- Testing
- Torrent's Rosuvastatin Calcium Tablets 40 mg, Crestor 40 mg Tablets of AstraZeneca LP, USA
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Volunteers
A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults
This is a bioequivalence trial to evaluate the bioequivalence of Myrin P Forte against reference drug in healthy volunteers.
- Trial name
- NCT01399788
- Testing
- Myrin P Forte, Single drug references
- Where
- Singapore
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an equivalent oral dose of a commercially…
- Trial name
- NCT00853554
- Testing
- Hydromorphone Hydrochloride tablet 8 mg, Dilaudid® tablet 8 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Fasting
Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition
This is a open Label, balanced, randomized, single dose, two-treatment, two-sequence, two-period, crossover, oral pivotal bioequivalence study.
- Trial name
- NCT01827865
- Testing
- Etodolac Extended Release Tablets USP 600mg, Etodolac Extended Release Tablets 600mg
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Treatment of Episodic Tension Headache
Efficacy and Safety Clinical Trial of the Combination of Acetylsalicylic Acid, Sodium Bicarbonate and Citric Acid, Produced by Geolab Pharmaceutical Industries Ltd., Compared to Acetylsalicylic Acid (Aspirin ® - Bayer) in Patients With Episodic Tension-type Headache.
This study aims is to evaluate, two hours after a single administration, the rate of sustained response produced by the association Geolab consisting of acetylsalicylic acid, sodium bicarbonate and anhydrous citric acid - oral…
- Trial name
- NCT01012349
- Testing
- Association: acetylsalicylic acid (500mg), sodium bicarbonate (1625) and citric acid (965), Aspirin - Bayer
- Where
- Brazil
- Volunteers
- 152 people
- Sponsor
- Azidus Brasil
Asthma, COPD
An Open Study to Assess the Robustness of the CRC749 Inhaler
To confirm the robustness of the CRC749 inhaler.
- Trial name
- NCT02474017
- Testing
- MGR001, CRC749 inhaler
- Where
- 2 sites in United Kingdom
- Volunteers
- 111 people
- Sponsor
- Mylan Pharma UK Ltd.
Osteoporosis, Postmenopausal
Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General…
- Trial name
- NCT05419427
- Testing
- Denosumab, Denosumab-Ref
- Where
- India
- Volunteers
- 552 people
- Sponsor
- Lambda Therapeutic Research Ltd.