Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed…
- Trial name
- NCT01018342
- Testing
- Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg, Macrobid® Capsules 100 mg
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Pain
Bioequivalence Study for Mejoral 500 Product
This will be a monocentric, single blinded, randomized, single-dose, two-periods, two-sequence, crossover bioequivalence study of two oral formulations in healthy participants under fasting conditions.
- Trial name
- NCT02504775
- Testing
- Mejoral® 500 Tablets, Tylenol® Caplets
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis
Bioequivalence Study of Azelastine Hydrochloride/ Fluticasone Propionate 137 Microgram/50 Microgram Nasal Spray and Dymista Nasal Spray
Single dose (four sprays) bioequivalence study of Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray and 'DYMISTA' (Azelastine Hydrochloride/Fluticasone Propionate) Nasal Spray 137…
- Trial name
- NCT06180083
- Testing
- Azelastine Hydrochloride/ Fluticasone propionate nasal spray, 'DYMISTA' NASAL SPRAY
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalence, Fixed Dose Combination Tablets
A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects
This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions
- Conditions
- Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
- Trial name
- NCT02637037
- Testing
- dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg
The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5…
- Trial name
- NCT00649454
- Testing
- Glipizide and Metformin HCl Tablets 5 mg/500 mg, Metaglip® Tablets 5 mg/500 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Tuberculosis
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane®…
- Trial name
- NCT01311505
- Testing
- Myrin© 2 (Rifampicin + Isoniazid), Rimactane® (Rifampicin)
- Where
- Philippines
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Viral Infection, COVID-19
Pharmacokinetics and Bioequivalence of Molnupiravir, 200 mg Capsules and Lagevrio, 200 mg Capsules in Healthy Volunteers
The study aimed for: 1. Comparative evaluation of the safety of the drug Molnupiravir, capsules, 200 mg (JSC "Valenta Pharm", Russia), and Lagevrio, capsules, 200 mg (Merck Sharp \& Dohme (UK) Limited, UK), based on the analysis…
- Trial name
- NCT05412173
- Testing
- Molnupiravir
- Where
- Russia
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy
A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.
- Trial name
- NCT00602589
- Testing
- Levofloxacin oral suspension; Levofloxacin oral solution; and Levofloxacin marketed tablet formulations
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy Subjects
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablets Under Fed Conditions
Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.
- Trial name
- NCT02965274
- Testing
- Torrent's Fluoxetine Tablets, Warner Chilcott LLC's Sarafem Tablet
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Fasting Study of Anagrelide Hydrochloride Capsules 1 mg to Agrylin® Capsules 1 mg
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1 mg capsules to Shire US's Agrylin® 1 mg capsules following a single, oral 1 mg (1 x 1 mg) dose administration under fasting conditions.
- Trial name
- NCT00648024
- Testing
- Anagrelide Hydrochloride Capsules 1 mg, Agrylin® Capsules 1 mg
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Amlodipine 10 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets under fasting conditions.
- Trial name
- NCT00841542
- Testing
- Amlodipine Besylate, Norvasc®
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Study Comparing Two Different Tablet Formulations Of Bosutinib
This study is comparing 2 formulations of bosutinib in healthy subjects.
- Trial name
- NCT00934674
- Testing
- SKI-606 (Bosutinib)
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan
Study Design : A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study
- Trial name
- NCT01197014
- Testing
- Amlodipine plus Losartan, Amlodipine, Losartan
- Where
- Czechia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Irritable Bowel Syndrome, Gallstone Disease
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in…
- Conditions
- Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia
- Trial name
- NCT07421011
- Testing
- Trimedat®
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Allergic Rhino-Conjunctivitis, Urticaria
To Compare and Evaluate the Oral Bioavailability of Bilastine 20 mg Orally Dispersible Tablet With That of Bilaxten (Bilastine) 20 mg Orally Dispersible Tablet in Healthy, Adult, Human Subjects Under Fasting Conditions
An open label, balanced, randomized single-dose, two-treatment, two sequence, four-period, Full Replicate, crossover oral bioequivalence study in healthy, adult, human subjects under fasting condition.
- Trial name
- NCT07042828
- Testing
- Bilastine oral dispersible tablets, Bilaxten oral dispersible tablets
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting Conditions
An open-label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, bioequivalence study of Mycophenolate mofetil 250 mg Capsule of Dr.
- Trial name
- NCT01513044
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Volunteers Bioequivalence or Bioavailability Study
A Study to Assess the Relative Bioavailability of Process Variants of Selumetinib in Healthy Male Volunteers
A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant of selumetinib capsule are comparable, and to assess how drug levels differed in another variant of Selumetinib in Healthy Male…
- Trial name
- NCT02322749
- Testing
- selumetinib 75mg single dose
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Study of Lamotrigine 2×25 mg IR Tablets of Torrent Pharmaceuticals Limited, India and Lamictal® (Lamotrigine) 2×25 mg Tablets of GlaxoSmithKline, USA, in Healthy Human Adult Subjects, Under Fasting Conditions.
Objective: A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Lamotrigine 2 x 25mg IR tablets of Torrent Pharmaceuticals Limited, India and Lamictal ® (Lamotrigine)…
- Trial name
- NCT00939614
- Testing
- Lamotrigine
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg
The objective of this study was to investigate the bioequivalence of Mylan's ondansetron 24 mg tablets to GSK's Zofran® 24 mg tablets following a single, oral 24 mg (1 x 24 mg) dose administered under fasting conditions.
- Trial name
- NCT00649532
- Testing
- Ondansetron Tablets 24 mg, Zofran® Tablets 24 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Essential Hypertension
A Bioequivalence Study of L04TD3 Compared to Administration of L04RD1 in Healthy Volunteers
This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD3 in healthy volunteers.
- Trial name
- NCT05993806
- Testing
- L04RD1, L04TD3
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Celltrion
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